9 results
  • A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma. - NCT04133636

    To evaluate the overall minimal residual disease (MRD) negative rate of subjects who receive JNJ-68284528.

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    • Protocol Number:
      011909

    • Principal Investigator:
      Rajat Bannerji Dr.

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

    • Drugs Involved:
      JNJ-68284528

      • Contacts:

      • Rutgers University Prinicipal Investigator: Rajat Bannerji Dr.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Cohort A: Received a minimum of 1 to a maximum of 3 prior lines of therapy including a proteasome inhibitor (PI) and immunomodulatory therapy (IMiD), and lenalidomide refractory per International Myeloma Working Group (IMWG) guidelines
    • Cohort B: Received one line of prior therapy including a PI and an IMiD, and disease progression per IMWG criteria less than or equal to (<=) 12 months after treatment with autologous stem cell transplantation (ASCT) or <=12 months from the start of anti-myeloma therapy for participants who have not had an ASCT
    • Cohort C: Previously treated with a PI, an IMiD, an anti-CD38 monoclonal antibody and B-cell maturation antigen (BCMA)-directed therapy
    • Cohort D: Newly diagnosed multiple myeloma per IMWG with a history of 4 to 8 total cycles of initial therapy, including induction, high-dose therapy, and ASCT with or without consolidation
    • Cohort E: Have newly diagnosed multiple myeloma without prior therapy (one cycle of prior therapy before enrollment is acceptable) and classified as high risk defined as either: 1) International Staging System (ISS) stage III criteria, Beta 2 microglobulin greater than or equal to (>=) 5.5 milligram per liter (mg/L) (via local or central laboratory assessment) or 2) high risk cytogenetic features del(17/17p), t (14;16), t(14;20), 1q amplification (at least 4 total copies) in at least 20 percent (%) of the total plasma cell population
    • Cohort F:
    • Participant must have a documented efficacy response of very good partial response (VGPR) or better, without progressive disease prior to enrollment, as assessed per IMWG 2016 criteria
    • Received 4 to 8 cycles of initial therapy as specified below. The dose/schedule of cycles administered will be as per standard of care. Up to 1 cycle of the regimens specified may not include one agent listed (example, held due to toxicity), acceptable combinations include: at least 5 to 8 cycles of initial therapy with daratumumab, bortezomib, lenalidomide and dexamethasone (D-VRd). The dose/schedule of cycles administered will be as per standard of care or; daratumumab, lenalidomide and dexamethasone (D-Rd) or; a carfilzomib-based triplet or quadruplet regimen
    • Cohorts A, B, C, E:
    • Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours
    • Light chain multiple myeloma in whom only measurable disease is by serum free light chain (FLC) levels in the serum: Serum immunoglobulin FLC >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
    • Cohort A: For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole -body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria. A minimum of one lesion with a bi-dimensional measurement of at least 1 centimeter (cm)*1 cm is required
    • Cohorts B, C: For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria
    • Cohorts A, B, C, D, E, F: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

    Exclusion Criteria:

    • Cohorts A, B, D, F: Any therapy that is targeted to BCMA
    • Cohorts A, B, C, D, F: Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
    • Cohorts A, B, C, D, F:
    • Ongoing toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
    • Received a cumulative dose of corticosteroids equivalent to >=70 mg of prednisone within the 7 days (Cohort A, B, C, F) or 14 days (Cohort D) prior to apheresis
    • Serious underlying medical condition, such as (a) evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection; (b) active autoimmune disease or a history of autoimmune disease within 3 years; (c) overt clinical evidence of dementia or altered mental status; (d) any history of Parkinson's disease or other neurodegenerative disorder
    • Cohorts A, B, C, D, E, F: Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of MK-7684A (MK-7684 [Vibostolimab] with MK-3475 [Pembrolizumab] Coformulation) in Participants with Relapsed or Refractory Hematological Malignancies - NCT05005442

    Primary Objective: To determine the safety and tolerability of MK-7684A (Cohorts A to F). Secondary Objective: To evaluate ORR following administration of MK-7684A (Cohorts A to F) per disease-specific criteria as assessed by Investigator To evaluate the DOR following administration of MK-7684A (Cohorts A to F) To evaluate the DCR following administration of MK-7684A (Cohorts A to F) To characterize the PK profile of vibostolimab (Cohorts A to F)

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    • Protocol Number:
      012109

    • Principal Investigator:
      Rajat Bannerji Dr.

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma,Multiple Myeloma,Hodgkin's Lymphoma

      • Contacts:

      • Rutgers University Prinicipal Investigator: Rajat Bannerji Dr.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria

    • Have confirmed relapsed/refractory classic Hodgkins Lyphoma (cHL), Primary mediastinal B-cell lymphoma (PMBCL), Follicular Lymphoma (FL), Diffuse large B-cell lymphoma (DLBCL) or Non-Hodgkins Lymphoma (NHL), or multiple myeloma (MM). For PMBCL, DLBCL, FL, and MM:
    • Must be relapsed or refractory to CAR-T-cell therapy or unable to receive it. For DLBCL and NHL:
    • Must have exhausted or be ineligible for or intolerant to all treatments, which in the opinion of the investigator are standard of care for their disease. For NHL:
    • Participants with Mantle cell lymphoma (MCL) must have received prior Bruton's tyrosine kinase inhibitor therapy. All participants:
    • Have measurable disease.
    • Have adequate organ function.
    • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation.
    • Must be able to provide newly obtained bone marrow biopsy or aspirate material for disease assessment.
    • Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of non child-bearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle.

    Exclusion Criteria

      For DLBCL and NHL:
    • Has lymphoplasmacytic lymphomas, Waldenstrom's macroglobulinemia, chronic lymphocytic leukemia (not associated with small lymphocytic lymphoma), Burkitt (-like) lymphoma, mature T cell and NK cell neoplasms, immunodeficiency associated lymphoproliferative neoplasms, or histiocytic and dendritic cell neoplasms. For MM:
    • Has oligo-secretory myeloma, plasma cell leukemia, smoldering multiple myeloma, or monoclonal gammopathy of undetermined significance.
    • Has a history of primary amyloidosis, hyperviscosity or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
    • Has known prior or current central nervous system (CNS) involvement. For Epstein Barr virus (EBV) positive DLBCL:
    • Associated with a solid organ transplant. For all participants:
    • A WOCBP who has a positive urine pregnancy test within 72 hours before study intervention allocation.
    • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.
    • Has a history of a second malignancy.
    • Any PMBCL participants that require the use of urgent cytoreductive therapy.
    • If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery before starting study intervention.
    • Has received prior radiotherapy within 2 weeks of start of study intervention.
    • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
    • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
    • Has a known severe hypersensitivity to MK-7684A, vibostolimab or pembrolizumab and/or any of its excipients.
    • Has a known history of Human Immunodeficiency Virus (HIV) infection.
    • Has an active autoimmune disease that has required systemic treatment in past 2 years.
    • Has an active infection requiring systemic therapy.
    • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
    • Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before enrollment.
    • Has dual active HBV infection (HBsAg (+) and /or detectable HBV DNA) and Hepatitis C (HCV) infection (anti-HCV Ab (+) and detectable HCV RNA) at study entry..
    • Has had an allogenic hematopoietic stem cell/solid organ transplantation within the last 5 years.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant. - NCT03901963

    Primary Objective: To evaluate conversion rate to minimal residual disease (MRD) negativity following the addition of daratumumab to lenalidomide relative to lenalidomide alone, when administered as maintenance treatment to anti-CD38 treatment naive patients with newly diagnosed multiple myeloma who are MRD positive as determined by next generation flow (NGF) or next generation sequencing (NGS) following high-dose therapy (HDT) and autologous stem cell transplant (ASCT), with or without consolidation therapy. Secondary Objective: To further evaluate the efficacy, health-related quality of life, and safety of daratumumab in combination with lenalidomide as maintenance treatment for patients with newly diagnosed multiple myeloma.

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    • Protocol Number:
      011912

    • Principal Investigator:
      Mansi Shah MD

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Daratumumab LENALIDOMIDE

      • Contacts:

      • Rutgers University Prinicipal Investigator: Mansi Shah MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Must have newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) within 12 months of the start of induction therapy, and be within 6 months of ASCT on the date of randomization
    • Must have a very good partial response (VGPR) or better response assessed per International Myeloma Working Group (IMWG) 2016 criteria at the time of randomization
    • Must have archived bone marrow samples collected before induction treatment (that is, at diagnosis) or before transplant (for example, at the end of induction) or have existing results on the index multiple myeloma clone based on Adaptive Biotechnologies' next generation sequencing (NGS)-based minimal residual disease (MRD) assay. Archived bone marrow samples will be used for calibration of myeloma clonal cells to facilitate assessment of primary end point by NGS. If an existing result on index myeloma clone is available from Adaptive Biotechnologies' NGS-based MRD assay, as part of institutional procedures, an archived bone marrow sample is not required as long as Adaptive Biotechnologies is able to retrieve historical results on the index myeloma clone form the clinical database. Any one of the following archived samples are required: (a) Greater than 1 milliliter (mL) viable frozen bone marrow aspirated aliquot (preferred) collected in an ethylenediaminetetra-acetic acid (EDTA) tube, frozen, and stored at a temperature of -80 centigrade (°C), or; (b) Non-decalcified diagnostic bone marrow aspirate clot sections (block or slides) for MRD assessment: (i) A formalin fixed paraffin embedded (FFPE) block of bone marrow aspirate clot, or slides (preferably 5, if available), 5 micrometer each, of non-decalcified bone marrow, or; (ii) Slides (preferably 5, if available), bone marrow aspirate smear; (iii) Please note, bone marrow core sections are not acceptable samples for analysis; (iv) In exceptional circumstances when index myeloma clone cannot be identified from the archived bone marrow sample, a post-transplant sample can be used to identify myeloma clone with permission from the sponsor
    • Must have residual disease as defined by detectable MRD (Adaptive Biotechnologies' NGS based MRD assay)
    • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

    Exclusion Criteria:

    • A history of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease before the of date of randomization. Exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years
    • Must not have progressed on multiple myeloma (MM) therapy at any time prior to screening
    • Have had prior treatment/therapy with: (a) Daratumumab or any other anti-cluster of differentiation 38 (CD38) therapies, (b) Focal radiation therapy within 14 days prior to randomization with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma. Radiotherapy within 14 days prior to randomization on measurable extramedullary plasmacytoma is not permitted even in the setting of palliation for symptomatic management, or (c) Plasmapheresis within 28 days of randomization
    • Be exhibiting clinical signs of meningeal or central nervous system involvement due to multiple myeloma
    • Have known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) less than (<) 50 percent (%) of predicted normal
    • Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification
    • Have any of the following: (a) Known history of seropositivity for human immunodeficiency virus (HIV); (b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]. Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR; (c) Seropositive for hepatitis C (anti-hepatitis C virus [HCV] antibody positive or HCV-RNA quantitation positive), except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy)

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • Expanded Access Protocol (EAP) for Patients Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release. - NCT04771078

    The primary objective is to assess the safety of nonconforming ide-cel. The secondary objective is to assess the efficacy of nonconforming ide-cel. The exploratory objectives are to assess duration of response, progression -free survival, and overall survival.

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    • Protocol Number:
      012102

    • Principal Investigator:
      Dennis Cooper M.D

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      CYCLOPHOSPHAMIDE FLUDARABINE BB2121 (Idecabtagene Vicleucel)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Dennis Cooper M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Had a participant-specific batch of Idecabtagene vicleucel (ide-cel) manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria
    • Remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the participant
    • Clinically stable

    Exclusion Criteria:

    • Has a hypersensitivity to the active substance or to any of the excipients
    • No experience of a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of Adverse Events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming Idecabtagene vicleucel (ide-cel)
    • Has any condition and/or laboratory abnormality that places the participant at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement Other protocol-defined inclusion/exclusion criteria apply

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • Expanded Access Protocol (EAP) for Patients Receiving Lisocabtagene Maraleucel That is Nonconforming for Commercial Release - NCT04400591

    The primary objective is to assess the safety of nonconforming lisocabtagene maraleucel in patients. The secondary objective is to assess efficacy of nonconforming lisocabtagene maraleucel in patients. The exploratory objectives are to assess duration of response (DOR), progression- free survival(PFS), and overall survival (OS).

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    • Protocol Number:
      012004

    • Principal Investigator:
      Dennis Cooper M.D

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Hodgkin's Lymphoma,Multiple Myeloma,Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      lisocabtagene maraleucel / JCAR017

      • Contacts:

      • Rutgers University Prinicipal Investigator: Dennis Cooper M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Subject and/or LAR must understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted. 2. Subject has relapsed and/or refractory large B-cell lymphoma and is, per the treating physician assessment, eligible for treatment with lisocabtagene maraleucel per the approved prescribing information. 3. Subject is ≥ 18 years of age at the time of signing the informed consent form. 4. Subject had a specific batch of lisocabtagene maraleucel manufactured intended for commercial treatment; however, the final manufactured product did not meet commercial release criteria. 5. Remanufacturing (eg, repeat leukapheresis and manufacturing) is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the subject. 6. Subject is clinically stable, has recovered from any toxicities prior to receiving lymphodepleting chemotherapy, and has adequate bone marrow function to receive lymphodepleting chemotherapy. The treating physician is advised to contact Medical Monitor in the event there is any concern regarding administration of lymphodepleting chemotherapy. 7. Females of childbearing potential must: 1. Have a negative pregnancy test as verified by the treating physician within 7 days prior to the first dose of lymphodepleting chemotherapy following institutional testing methodology practices. This applies even if the subject practices true abstinence from heterosexual contact. 2. Either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective contraception without interruption. Contraception methods must include 1 highly effective method from screening until at least 12 months after the nonconforming lisocabtagene maraleucel administration. 3. Agree to abstain from breastfeeding during study participation and for at least 12 months following nonconforming lisocabtagene maraleucel administration. 4. There are insufficient exposure data to provide any recommendation concerning the duration of contraception and the abstaining from breastfeeding following treatment with lisocabtagene maraleucel. Any decision regarding contraception and breastfeeding after infusion should be discussed with the treating physician. 8. Male subjects must: 1. Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for at least 12 months after nonconforming lisocabtagene maraleucel administration even if the subject has undergone a successful vasectomy. 2. There are insufficient exposure data to provide any recommendation concerning the duration of contraception following treatment with lisocabtagene maraleucel. Any decision regarding contraception after infusion should be discussed with the treating physician 9. Subject must agree to not donate blood, organs, tissue, sperm or semen and egg cells for usage in other individuals for at least 1 year following nonconforming lisocabtagene maraleucel administration.

    Exclusion Criteria:

      1. Subject has a hypersensitivity to the active substance or to any of the excipients. 2. Subject should not experience a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of adverse events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming lisocabtagene maraleucel. 3. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness, sociologic or geographic condition that would prevent the subject from participating in the Expanded Access Protocol complying with protocol requirements in the Investigator's judgement. 4. Subject has any condition and/or laboratory abnormality that places the subject at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement 5. Pregnant or nursing women or has intention of becoming pregnant during the study. 6. Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study). 7. Subject has active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at the time of pretreatment evaluation 8. Subject has uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of nonconforming lisocabtagene maraleucel administration. 9. Subject has presence of acute or chronic graft-versus-host disease (ie, GVHD) 10. Use of the following: 1. Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 72 hours prior to nonconforming lisocabtagene maraleucel administration. Physiologic replacement, topical, and inhaled steroids are permitted. 2. Low dose chemotherapy (eg, vincristine, rituximab, cyclophosphamide ≤ 300 mg/m2)given after leukapheresis to maintain disease control must be stopped ≥ 7 days prior to lymphodepleting chemotherapy. 3. Cytotoxic chemotherapeutic agents that are not considered lymphotoxic (see below) within 1 week of LD chemotherapy. Oral chemotherapeutic agents, including lenalidomide and ibrutinib, are allowed if at least 3 half-lives have elapsed prior to lymphodepleting chemotherapy. 4. Donor lymphocyte infusions within 6 weeks of nonconforming lisocabtagene maraleucel administration.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • Machine Learning-based High-throughput and Integrative Immunological Synapse Quality Evaluation As a Composite Biomarker for Predicting CAR Therapy Efficacy in Immuno-Oncology

    1. The primary objective is to determine if a novel fluorescent assay measuring dynamic parameters of immune synapse quality can be used to assess commercial T cell products. 2. The secondary objective is to determine if a novel fluorescent assay measuring dynamic parameters of the immune synapse can be used as a biomarker to associate with CAR-T cell efficacy and toxicity.

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    • Protocol Number:
      012108

    • Principal Investigator:
      Roger Strair M.D., Ph.D.

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Hodgkin's Lymphoma,Multiple Myeloma,Non-Hodgkin's Lymphoma

      • Contacts:

      • Rutgers University Prinicipal Investigator: Roger Strair M.D., Ph.D.
    • Rutgers Cancer Institute of New Jersey
  • Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients with Relapsed or Refractory Multiple Myeloma. - NCT03761108

    In the Phase 1 portion of the study: (1)To assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended Phase 2 dose regimen (RP2DR) (defined as either a maximum tolerated dose regimen [MTDR] or biologically effective dose regimen [BEDR]) of REGN5458 as monotherapy in patients with relapsed or refractory multiple myeloma (MM) who have exhausted therapeutic options. In the Phase 2 portion of the study: To assess the preliminary anti-tumor activity of REGN5458. The secondary objectives of the study are: (1). To evaluate the pharmacokinetic (PK) properties of REGN5458 (2). To characterize the immunogenicity of REGN5458 In the Phase 1 portion only: (1). To assess the preliminary anti-tumor activity of REGN5458 In the Phase 2 portion only: (1). To evaluate the safety and tolerability of REGN5458 (2). To evaluate the correlation between the activity of REGN5458 and PK

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    • Protocol Number:
      011818

    • Principal Investigator:
      Mansi Shah MD

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      REGN5458

      • Contacts:

      • Rutgers University Prinicipal Investigator: Mansi Shah MD

    Read Inclusion & Exclusion Criteria

    Key Inclusion Criteria:

    • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
    • Confirmed diagnosis of active Multiple Myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria
    • Patients must have myeloma that is response-evaluable according to the 2016 IMWG response criteria.
    • Phase 1 Dose Escalation: Patients with MM who have exhausted all therapeutic options that are expected to provide meaningful clinical benefit, either through disease relapse, treatment refractory disease or intolerance of the therapy and including either: 1. Progression on or after at least 3 lines of therapy, or intolerance of therapy, including a proteasome inhibitor, an Immunomodulatory agent (IMiD), and an anti-CD38 antibody, OR 2. Progression on or after an anti-CD38 antibody and have disease that is "double refractory" to a proteasome inhibitor and an IMiD, or intolerance of therapy. The anti-CD38 antibody may have been administered alone or in combination with another agent such as a proteasome inhibitor. Refractory disease is defined as lack of response or relapse within 60 days of last treatment. Phase 2: 3. Patients must be triple-refractory, defined as being refractory to prior treatment with at least 1 anti-CD38 antibody, a proteasome inhibitor, and an IMiD. In addition, patients must be penta-exposed (ie, having prior exposure to 2 PIs, 2 IMiDs [lenalidomide and pomalidomide], and 1 anti-CD38 monoclonal antibody). Refractory disease is defined as progression during treatment or within 60 days after completion of therapy, or less than 25% response to therapy.

    Key Exclusion Criteria:

    • Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis, (excluding myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
    • Patients with known MM brain lesions or meningeal involvement
    • Prior treatment with BCMA-directed immunotherapies, including BCMA bispecific antibodies and BiTEs, and BCMA CAR T cells. Note: BCMA antibody-drug conjugates are not excluded
    • History of allogeneic stem cell transplantation at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment Note: Other protocol defined inclusion / exclusion criteria apply

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • Post-Transplant Use of Irradiated Haplo-Allogeneic Cells - NCT03272633

    ? Primary Objective The primary objective is to determine the toxicity associated with the administration of IHC to patients with high-risk hematologic malignancies. ? Secondary Objective To secondary objective is to determine if there is evidence of disease response associated with IHC. This will be determined by standard disease staging, use of minimal residual disease markers, and/or by clinical analysis by the Hematologic Malignancies Tumor Study Group as directed by disease and disease state. ? Tertiary Objective To determine if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes.

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    • Protocol Number:
      011702

    • Principal Investigator:
      Roger Strair M.D., Ph.D.

    • Phase:
      Early Phase I

    • Scope:
      Local

    • Applicable Disease Sites:
      Lymphoid Leukemia,Multiple Myeloma,Leukemia, other,Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Bone Marrow Transplant

      • Contacts:

      • Rutgers University Prinicipal Investigator: Roger Strair M.D., Ph.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patient with disease (stage) eligible per cohort
    • COHORT 1: patients undergoing high dose chemotherapy with autologous stem cell rescue and ?high-risk? disease as defined below:
    • Diffuse large cell lymphoma or peripheral T cell lymphoma (including specified World Health Organization [WHO] subtypes) not in computed tomography (CT)-positron emission tomography (PET) complete remission at time of high dose therapy
    • Diffuse large cell lymphoma with ?double hit? or ?double expressor? features
    • Diffuse large cell lymphoma or peripheral T cell lymphoma (including WHO specified subtypes) refractory to standard induction therapy OR relapsing within 1 year of treatment OR in greater that second complete remission (CR)
    • Mantle cell lymphoma not in CR1
    • Multiple myeloma with ONE (or more) of the following high risk features:
    • Less than very good partial remission at time of high dose therapy
    • High Revised-International Staging System (R-ISS) (stage III ? 2 microglobulin >= 5.5 plus lactate dehydrogenase [LDH] > upper limit of normal [ULN] and/or del17p, t(4;14), t(14;16)) at time of diagnosis
    • Cytogenetics or fluorescent in situ hybridization (FISH) del17p
    • COHORT 2: patients with high risk disease having undergone an allogeneic hematopoietic stem cell transplant from a 10/10 human leukocyte antigen (HLA) matched donor with one of the following disease subtypes:
    • Acute myeloid leukemia (AML) in CR1 with high risk features (European Leukemia Network [ELN]) at presentation
    • Diagnostic sample with either t(6;9), t(9;22), 11q23, inv 3, -5, -7, del17p, complex cytogenetics, NPMwt-flt3ITD+, OR p53 mutation (mut); patients whose samples have mutations in RUNX1 or ASXL1 are also eligible (unless the patient has favorable cytogenetics)
    • AML in CR1 with measurable minimal residual disease (MRD) by molecular (e.g., myeloid mutation profile, polymerase chain reaction [PCR] for NPM1, core-binding factor [CBF], mixed lineage leukemia [MLL]) or flow cytometry
    • AML not in CR1 (including patients with morphologic CR but with incomplete recovery, CRi)
    • Myelodysplastic syndrome (MDS) with complex cytogenetics, 17p deletion or p53 mutation, or JAK2 or RAS mutation
    • Treatment-related MDS or AML
    • Acute lymphoblastic leukemia (ALL) not in CR1
    • ALL with MRD
    • Any hematologic malignancy relapsed or with persistent disease after allogeneic hematopoietic stem cell transplant
    • Multiple myeloma
    • Non-Hodgkin lymphoma (NHL) with chemoresistant disease at time of transplant
    • Any patient undergoing allogeneic hematopoietic stem cell transplant and an anticipated rate of relapse > 80% based upon published data and for which there is consensus amongst the Hematologic Malignancies Tumor Study Group that enrollment is appropriate
    • Availability of a genetic child, genetic parent or sibling as a potential HLA haploidentical donor
    • Meets standard eligibility requirements for high dose chemotherapy with autologous stem cell rescue (COHORT 1) or allogeneic hematopoietic stem cell transplant (COHORT 2) and has signed consent for those procedures
    • DONOR: Donor must be related to patient and be partially (>= 3/6 antigen) HLA-matched
    • DONOR: Donor must meet all Robert Wood Johnson (RWJ) Blood Services requirements for hematopoietic stem cell donation including:
    • Age >= 18 years old;
    • Normal hemogram (white blood cells [WBC] 4.0-10.0 x 10^3/mm^3; platelet count 150,000 to 440,000/mm^3 ; hemoglobin/hematocrit; 12.5-18 g/dl, 38 to 54%
    • Not pregnant or lactating;
    • Not human immunodeficiency virus (HIV)-1, HIV-2, hepatitis C virus (HCV), hepatitis B core or human T-cell lymphotropic virus (HTLV)-I/II seropositive; hepatitis B surface antigen (HB S ag) (-); meet other infectious disease screening criteria utilized by RWJ Blood Services;
    • No uncontrolled infections, other medical or psychological/social conditions, or medications that might increase the likelihood of patient or donor adverse effects or poor outcomes;
    • Meet other blood bank criteria for blood product donation (as determined by RWJ Blood Center screening history and laboratory studies)

    Exclusion Criteria:

    • Non-English speaking person
    • Patients undergoing haploidentical allogeneic hematopoietic stem cell transplants are not eligible; patients undergoing < 10/10 HLA allele matched allogeneic transplant are not eligible
    • Pregnant women
    • DONOR: Non-English speaking person
    • DONOR: Pregnant women

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • The Prophylactic Use of Loratadine for Granulocyte-Colony Stimulating Factor (G-CSF) Induced Bone Pain in Multiple Myeloma Patients Undergoing Stem Cell Mobilization - NCT04211259

    The primary objective of this study is to evaluate the efficacy of the second-generation antihistamine, loratadine, as prophylaxis for filgrastim (i.e., Neupogen, Zarxio) induced bone pain during stem cell mobilization in multiple myeloma patients. The secondary objectives are to (1) examine the frequency and quantity of supportive analgesic medications needed in addition to loratadine or placebo for filgrastim induced bone pain and (2) identify risk factors associated with developing filgrastim induced bone pain.

    View All Details
    • Protocol Number:
      011910

    • Principal Investigator:
      Mansi Shah MD

    • Phase:
      Early Phase I

    • Scope:
      Local

    • Applicable Disease Sites:
      Multiple Myeloma,Bones and Joints,Ill-Defined Sites

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Loratadine/Placebo Pegfilgrastim

      • Contacts:

      • Rutgers University Prinicipal Investigator: Mansi Shah MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patient must be able to provide informed consent
    • Patients with confirmed diagnosis of multiple myeloma
    • Able to swallow and retain oral medication
    • All ethnic groups are eligible

    Exclusion Criteria:

    • Non-English speaking person
    • Patients undergoing haploidentical allogeneic hematopoietic stem cell transplant
    • Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
    • Any medical complications or conditions that would, in the investigator's judgement, interfere with full participation in the study
    • On therapeutic dose of aspirin (doses greater than 81 mg) within 7 days prior to the start of the study

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey