16 results
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  • A Phase 1 First in Human Study of ARV-393 in Adult Participants with Advanced Non-Hodgkins Lymphoma. - NCT06393738

    Primary Objective: To evaluate the safety and tolerability of ARV-393, determine MTD if necessary, and identify the RP2D(s) and dosing schedule. Secondary Objective: - To characterize the pharmacokinetic profile of ARV-393 in plasma, - To assess the preliminary anti-tumor activity of ARV-393.

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    • Protocol Number:
      012406

    • Principal Investigator:
      Matthew Matasar

    • Phase:
      Early Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      ARV-393

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • For Part A and B: Have relapsed/refractory NHL and >=2 prior systemic therapies, (including rituximab), and be ineligible for known therapies with demonstrated clinical benefit per investigator assessment or, histologically confirmed AITL that has recurred or progressed following institutional standard of care therapy.
    • For Part C and D: Have R/R DLBCL, not otherwise specified [NOS (DLBCL, NOS)] or large B-cell lymphoma (LBCL) arising from follicular lymphoma and have received two or more lines of systemic therapy.
    • Have at least one bi dimensionally measurable lesion >1.5-centimeter (cm) in largest dimension for nodal or >1.0 cm for extranodal lesion.
    • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (NOTE: For Part A only - ECOG PS of 2 is allowed for participants with secondary CNS lymphoma).
    • Adequate bone marrow function
    • Adequate kidney function
    • Adequate Liver Function

    Exclusion Criteria:

    • Current or past history of peripheral eosinophilia, hypereosinophilic syndrome (HES), organ-specific eosinophilic disorder, or drug reaction with eosinophilia and systemic symptoms (DRESS).
    • Prior allogeneic stem cell transplant (SCT) or solid organ transplantation.
    • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, melanoma in situ or carcinoma in situ of the breast or cervix, and prostate cancer with active surveillance.
    • Any of the following in the previous 6 months:
    • Myocardial infarction, long QT syndrome or family history of long QT syndrome, or Torsade de Pointes;
    • Clinically important atrial or ventricular arrhythmias;
    • Serious conduction system abnormalities, 3rd degree atrioventricular (AV block), unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), New York Heart Association Class III or IV;
    • Cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and/or other clinically significant episode of thromboembolic disease;
    • Active inflammatory gastrointestinal (GI) disease, chronic diarrhea, previous gastric resection, or lap band surgery.
    • Uncontrolled hypertension despite optimal medical treatment
    • History of myocarditis.
    • In ability to comply with listed prohibited treatments.
    • Standard 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
    • Cardiac ejection fraction <45%.

    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.

  • A Phase 1 Study of SynKIR-310, Autologous T Cells Transduced With CD19 KIR-CAR, in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma. - NCT06544265

    Primary: - To evaluate the safety of a single IV infusion of SynKIR-310 in participants with relapsed/refractory B cell Non- Hodgkin Lymphoma (B-NHL). - To determine the recommended Phase 2 dose (RP2D) of SynKIR-310 in participants with relapsed/refractory B-NHL. Secondary: - To evaluate feasibility of administering a single IV infusion of SynKIR-310 in participants with relapsed/refractory B cell Non-Hodgkin Lymphoma (B-NHL). - To evaluate preliminary efficacy measures of SynKIR-310 in participants with relapsed/refractory B-NHL.

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    • Protocol Number:
      012504

    • Principal Investigator:
      Matthew Matasar

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      SynKIR-310

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Adult 18 years of age and older.
    • Histologically confirmed diagnosis of B-NHL before enrollment.
    • Must have received prior CAR T or were unwilling/unable to receive prior CAR T.
    • Must have refractory or relapsed disease after receiving 2 prior lines of therapies.
    • If relapsed/refractory post-auto-SCT, then must have undergone auto-SCT at least 6 months prior to enrollment.
    • If relapsed/refractory disease after allogeneic stem cell transplant (allo SCT) then must have undergone allo-SCT at least 6 months prior to enrollment and without evidence of graft versus host disease, and expectation to remain off immunosuppressive therapy through duration of trial
    • Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014) or measurable disease per IWWM-11 response criteria (Treon 2023) for Waldenström macroglobulinemia patients.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

    Exclusion Criteria:

    • Previously treated with any investigational agent within 30 days prior to screening.
    • Any previous or concurrent malignancy, with the following exceptions:Adequately treated non-melanoma skin cancer such as basal cell or squamous cellcarcinoma; carcinoma-in-situ (e.g., cervix, bladder, breast) treated curatively andwithout evidence of recurrence for at least 3 years prior to enrollment or adequatelytreated melanoma skin cancer in-situ; any other malignancy which has been completelytreated and remains in complete remission for ≥ 5 years prior to enrollment. Completelytreated prostate cancer with prostate-specific antigen (PSA) level < 1.0 may also bepermitted.
    • Use of systemic immunosuppressive drugs within 4 weeks prior to study entry, or anticipated use of systemic immunosuppressive agents through end of study, with the exception of non-T cell targeting agents prior to leukapheresis
    • Known immunodeficiency disease , with the exception of hypoglobulinemia
    • History or presence of active or clinically relevant primary central nervous system (CNS) disorder, such as seizure, encephalopathy, cerebrovascular ischemia/hemorrhage, cerebellar disease, or any autoimmune disease with CNS involvement. For primary CNS disorders that have recovered or are in remission, participants without recurrence within 2 years of planned study enrollment may be included.
    • Uncontrolled hypertension, history of myocarditis or congestive heart failure, unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction within 6 months prior to study entry.
    • Any active uncontrolled systemic fungal, bacterial or viral infection.Note: Other protocol defined Inclusion/Exclusion criteria may 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.

  • A Phase 1 Study to Assess Safety and Tolerability of REGN5837, an Anti-CD22 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination with Odronextamab, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients with Aggressive B-Cell Non-Hodgkin Lymphomas (ATHENA-1) - NCT05685173

    The primary objective of the study is: - To assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine RP2D regimen(s) (defined as either a MTD regimen or a lower dose regimen) of REGN5837 in combination with odronextamab in patients with relapsed or refractory aggressive B-NHL. The secondary objectives of the study are: - To evaluate the pharmacokinetics (PK) of REGN5837 when given in combination with odronextamab - To evaluate the PK of odronextamab when given in combination with REGN5837 - To assess the immunogenicity of REGN5837 and odronextamab - To assess the preliminary anti-tumor activity of REGN5837 in combination with odronextamab in patients with relapsed or refractory aggressive B-NHL The exploratory objectives of the study are: - To evaluate the association between clinical efficacy and safety with biomarkers of systemic immune activation (serum cytokine levels, T-cell counts and activation markers) - To evaluate the association between disease response and/or relapse and the change from baseline in the count and phenotype of tumor-infiltrating T cells and tumor B cell target antigen (CD20, CD22) expression - To evaluate association of the molecular Minimal Residual Disease (MRD) status in patients with a clinical CR with progression-free survival (PFS) and OS - To assess other biomarkers (pharmacodynamic, predictive, and prognostic) potentially related to REGN5837 in combination with odronextamab exposure, anti-tumor activity, and safety - To evaluate the relationships among pharmacodynamics, drug concentrations, and clinical safety and efficacy measure

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    • Protocol Number:
      012303

    • Principal Investigator:
      Matthew Matasar

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Odronextamab(REGN1979) REGN5837

    Read Inclusion & Exclusion Criteria

    Key Inclusion Criteria:

      1. Have documented CD20+ aggressive B-NHL, with disease that has progressed after at least 2 lines of systemic therapy containing an anti-CD20 antibody and an alkylating agent, as described in the protocol. 2. Measurable disease on cross sectional imaging as defined in the protocol 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 4. Adequate bone marrow, renal and hepatic function as defined in the protocol 5. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed 6. During dose expansion phase of the study, participant should be willing to undergo mandatory tumor biopsies, if in the opinion of the investigator, the participant has an accessible lesion that can be biopsied without significant risk to the participant.

    Key Exclusion Criteria:

      1. Prior treatments with allogeneic stem cell transplantation or solid organ transplantation, treatment with anti-CD20 x anti- CD3 bispecific antibody, such as odronextamab 2. Diagnosis of Mantle Cell Lymphoma (MCL) 3. Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS lymphoma, as described in the protocol 4. Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 14 days prior to first administration of study drug, whichever is shorter, as described in the protocol 5. Standard radiotherapy within 14 days of first administration of study drug, as described in the protocol 6. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or corticosteroid equivalent within 72 hours of start of odronextamab 7. Co-morbid conditions, as described in the protocol 8. Infections, as described in the protocol 9. Allergy/hypersensitivity: Known hypersensitivity to both allopurinol and rasburicaseNOTE: 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
  • A Phase 3, Open Label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an anti CD20 × anti-CD3 Bispecific Antibody, in Combination with CHOP (O-CHOP) versus Rituximab in Combination with CHOP (R-CHOP) in Previously Untreated Participants with Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3). - NCT06091865

    Part 1 (safety run-in): Primary objective: To assess the safety, tolerability and dose limiting toxicities (DLTs) of odronextamab in combination with CHOP (O-CHOP) in participants previously untreated for Diffuse Large B-Cell Lymphoma (DLBCL) with high-risk features and determine the dose of odronextamab to combine with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in Part 2. Secondary objectives: a. To evaluate the preliminary anti-tumor activity of O-CHOP in participants with previously untreated DLBCL with high-risk features b. To evaluate the pharmacokinetics (PK) of odronextamab when administered in combination with CHOP c. To assess the immunogenicity of odronextamab when administered in combination with CHOP Part 2 (randomized portion): Primary objective: To compare the efficacy of O-CHOP with that of R-CHOP in participants with previously untreated DLBCL with an (International Prognostic Index) IPI score ≥3, and subsequently in all participants with an IPI score ≥2 Key secondary objective: To compare therapeutic benefit with O-CHOP versus that with R-CHOP assessed by event-free survival (EFS), complete response (CR) and overall survival (OS) Secondary objectives: a. To compare supplemental measures of efficacy for O-CHOP versus R-CHOP b. To compare safety and tolerability of O-CHOP with that of R-CHOP c. To evaluate the PK of odronextamab when administered in combination with CHOP d. To assess the immunogenicity of odronextamab when administered in combination with CHOP e. To compare measurable residual disease (MRD) with O-CHOP versus R-CHOP f. To compare the treatment effects on patient reported physical function between O-CHOP and R-CHOP g. To compare the treatment effects of O-CHOP versus R-CHOP on patient reported outcomes (PROs) including health-related quality of life, functioning and disease-related symptoms, as measured by EORTC QLQ-C30, FACT-LymS, EQ-5D-5L, two global anchors Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC), collected during study visits h. To evaluate the overall impact of treatment toxicity based upon the single item GP5 of the validated FACT-G questionnaire ( I am bothered by side effects of treatment )

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    • Protocol Number:
      012307

    • Principal Investigator:
      Matthew Matasar

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Odronextamab(REGN1979) RITUXIMAB

    Read Inclusion & Exclusion Criteria

    Key Inclusion Criteria:

      1. Previously untreated participants for lymphoma with documented Cluster of Differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL, for whom next available standard of care therapy is not available or deemed ineligible according to the investigator (Part 1A only) 2. Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 4. Life expectancy ≥ 12 months 5. International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only 6. Adequate hematologic and organ function, as defined in the protocol.

    Key Exclusion Criteria:

      1. Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology 2. Another active malignancy, significant active disease or medical condition, as described in the protocol 3. Peripheral neuropathy Grade ≥3 4. Treatment with any systemic anti-lymphoma therapy, except for participants with Relapsed/Refractory (R/R) DLBCL and participants with DLBCL transformed from an indolent lymphoma after treatment with systemic anti-lymphoma therapy. 5. Any other therapy or investigational treatment within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment 6. Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol 7. Allergy/hypersensitivity to study drugs, as described in the protocol 8. Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus Disease (COVID-19) infection, uncontrolled infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol.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.

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Jersey City Medical Center
  • A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination with Other Anticancer Agents in Participants with Mature B-Cell Malignancies. - NCT06564038

    Primary Safety: To assess the safety and tolerability SC AZD0486 as monotherapy (Cohort 1A) and in combination with acalabrutinib (Cohort 1B) in participants with R/R CLL/SLL who have received at least 1 prior line of therapy. Secondary Efficacy: To evaluate the preliminary efficacy of SC AZD0486 as monotherapy (Cohort 1A) and in combination with acalabrutinib (Cohort 1B) in participants with R/R CLL/SLL.

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    • Protocol Number:
      012408

    • Principal Investigator:
      Joanna Rhodes

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy multiple agents systemic Chemotherapy single agent systemic

    • Drugs Involved:
      acalabrutinib (ACP-196) AZD0486

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      Master Inclusion Criteria applicable to all substudies:

      • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
      • Contraception use during treatment and at least 90 days after final dose.
      • Confirmed CD19 expression if prior anti-CD19 therapy.

        Substudy 1 Specific Inclusion Criteria:

        • Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
        • SLL: at least 1 measurable site per Lugano.
        • Absolute lymphocyte count (ALC) <25000 cells/mcL.
        • Cohort 1A and 1C: at least 2 prior lines of systemic therapy for CLL/SLL.
        • Cohort 1B: at least 1 prior line of therapy and is bruton tyrosine kinase inhibitor (BTKi)-sensitive.

          Substudy 2 Specific Inclusion Criteria:

          • MCL diagnosis per WHO.
          • Clinical Stage II, III, or IV by Ann Arbor Classification.
          • At least 1 measurable site per Lugano.
          • ALC < 25000 cells/mcL.
          • Cohort 2A and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi.

            Substudy 3 Specific Inclusion Criteria:

            • At least 1 measurable site as per Lugano.
            • Left ventricular ejection fraction (LVEF) ≥50%.
            • Participant must be no older than 79 years of age at the time of signing ICF.
            • Contraception at least 90 days after last dose of surovatamig or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin.
            • Cohort 3A: 1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022. 2. R/R B-NHL after at least 1 prior lines of systemic therapy. 3. International Prognostic Index (IPI) 2-5.
            • Cohort 3B: 1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022. 2. IPI score of 2 to 5.

            Exclusion Criteria:

              Master Exclusion Criteria applicable to all substudies:

              • Central nervous system (CNS) lymphoma.
              • Surgery within 14 days of study drug.
              • Clinically significant cardiovascular (CV) disease.
              • Unresolved Grade >2 AEs from prior anticancer therapy (except alopecia or fatigue).
              • Any systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.
              • Radiation therapy within 28 days.
              • Prior CAR T-cell therapy or autologous-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks.
              • Prior Grade > 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event.
              • Prior allogeneic HSCT or solid organ transplantation within 24 weeks of starting Cycle 1 Day 1.
              • Active, significant, uncontrolled infection or autoimmune disease requiring systemic therapy including participants with known history of haemophagocytic lymphohistiocytosis (HLH).

              Substudy 1 Specific Exclusion Criteria:

              • CLL/SLL transformation to more aggressive form of lymphoma.
              • Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist.

              Substudy 3 Specific Exclusion Criteria:

              • Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL).
              • Cumulative dose of anthracycline >150 mg/m2.

      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.

    • A Phase III, Open-Label, Multicenter, Randomized Study Evaluating Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma. - NCT06084936

      Primary Objective: - To evaluate the efficacy of glofitamab monotherapy compared with an investigators choice of BR or R-Len with respect to PFS. Secondary Objectives: - To evaluate the efficacy of glofitamab monotherapy compared with an investigator s choice of BR or R-Len with respect to CRR. - To evaluate the efficacy of glofitamab monotherapy compared with an investigators choice of BR or R-Len with respect to ORR. - To evaluate the efficacy of glofitamab monotherapy compared with an investigators choice of BR or R-Len with respect to OS. - To evaluate the health-related quality of life of participants treated with glofitamab monotherapy compared with an investigator s choice of BR or R-Len.

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      • Protocol Number:
        012403

      • Principal Investigator:
        Matthew Matasar

      • Phase:
        Phase III

      • Scope:
        National

      • Applicable Disease Sites:
        Non-Hodgkin's Lymphoma

      • Therapies Involved:
        Chemotherapy multiple agents systemic

      • Drugs Involved:
        BENDAMUSTINE Gazyva (obinutuzumab) Glofitamab LENALIDOMIDE RITUXIMAB Tocilizumab

      Read Inclusion & Exclusion Criteria

      Inclusion Criteria:

      • Life expectancy at least 12 weeks
      • Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry
      • Relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen) disease
      • At least 1 line of prior systemic therapy including a BTK inhibitor and additional systemic therapy option
      • Confirmed availability of tumor tissue, unless deemed unsafe per investigator assessment
      • At least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion, or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on CT scan
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
      • Negative HIV test at screening
      • Adequate hematological function

      Exclusion Criteria:

      • Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of tocilizumab, 2 months after the final dose of glofitamab, whichever is longer
      • Leukemic, non-nodal MCL
      • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
      • Contraindication to obinutuzumab or rituximab, and either bendamustine or lenalidomide
      • Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
      • Prior treatment with CAR-T cell therapy
      • Treatment with systemic therapy or BTK inhibitors, or any investigational agent for the purposes of treating cancer within 2 weeks or 5 half-lives (whichever is shorter) prior to first study treatment
      • Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
      • Current or history of CNS disease, such as stroke, epilepisy, CNS vasculitis, or neurodegenerative disease
      • History of other malignancy that could affect compliance with the protocol or interpretation of results
      • Significant or extensive cardiovascular disease
      • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment
      • Suspected or latent tuberculosis
      • Positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV)
      • Known or suspected chronic active Epstein-Barr viral infection (EBV)
      • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
      • Known history of progressive multifocal leukoencephalopathy (PML)
      • Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better
      • Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
      • Prior solid organ transplantation or allogenic stem cell transplant
      • Eligibility for stem cell transplantation (SCT)
      • Active autoimmune disease requiring treatment
      • Prior treatment with systemic immunosuppressive medications within 2 weeks or five half-lives (whichever is shorter) prior to the first dose of study treatment
      • Corticosteroid therapy within 2 weeks prior to first dose of study treatment
      • Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
      • Clinically significant history of cirrhotic liver disease

      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.

      • Monmouth Medical Center
      • Rutgers Cancer Institute
    • A Randomized, Open-Label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants with Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma. - NCT06500273

      Primary: - To assess the efficacy of cema-cel vs. observation in participants with MRD+ LBCL. Secondary: - To assess the overall safety profile of cema-cel and ALLO-647 in participants with MRD+ LBCL.

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      • Protocol Number:
        012405

      • Principal Investigator:
        Matthew Matasar

      • Phase:
        Phase II

      • Scope:
        National

      • Applicable Disease Sites:
        Non-Hodgkin's Lymphoma

      • Therapies Involved:
        Chemotherapy multiple agents systemic

      • Drugs Involved:
        ALLO-647 cema-cel (cemacabtagene ansegedleucel)

      Read Inclusion & Exclusion Criteria

      Key Inclusion Criteria:

        1. LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by pathology report. 2. Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended. Participants cannot have received additional lines of therapy. 3. Participant achieved CR, or PR suitable for observation, at the end of first line therapy based on PET/CT evaluation 4. Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive. 5. Adult participants ≥18 years of age. 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 7. Adequate hematological, renal, hepatic, pulmonary, and cardiac function 8. Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1.

      Key Exclusion Criteria:

        1. LBCL with history of central nervous system involvement, transformed from other malignancy (e.g., transformed follicular lymphoma or marginal zone lymphoma, Richter's transformation), or T-cell/histiocyte rich LBCL. 2. Prior treatment with anti-CD19 targeted therapies. 3. Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed. 4. Active and clinically significant autoimmune disease. 5. Active systemic bacterial, fungal, or viral infections requiring systemic treatment. 6. History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to enrollment.

      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.

      • Cooperman Barnabas Medical Center
      • Rutgers Cancer Institute
    • Antibodies to Commensal Bacteria in Lymphoma Pathogenesis

      To determine if there is evidence of immune reactivity against commensal bacterial antigens in patients with B-cell non-Hodgkin lymphoma.

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      • Protocol Number:
        012209

      • Principal Investigator:
        Yun Kyoung Tiger

      • Phase:
        N/A

      • Scope:
        Local

      • Applicable Disease Sites:
        Non-Hodgkin's Lymphoma

      • Rutgers Cancer Institute
    • Characterizing Lymphoma Survivors Experiences, Needs, and Preferences During the Transition to Cancer Survivorship: The Survivor Health Check Program Development Trial.

      To assess information and support needs, preventive health behaviors symptoms, distress, preparedness for survivorship, and survivorship care experiences. To characterize level of interest in, preferred timing, potential delivery.

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      • Protocol Number:
        132203

      • Principal Investigator:
        Sharon Manne

      • Phase:
        N/A

      • Scope:
        Local

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

      • Rutgers Cancer Institute
    • Lisocabtagene Maraleucel as First-Line Therapy for Primary Central Nervous System Lymphoma (PCNSL) in Transplant-Ineligible Patients. - NCT07015242

      Primary: To evaluate whether liso-cel infusion results in improved efficacy, with respect to a theoretical value derived from historical references, in first line therapy for PCNSL in transplant-ineligible patients, based on investigator-assessed 12-month progression-free survival (PFS) probability. Secondary: To assess additional parameters of efficacy of lisocel in first line PCNSL.

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      • Protocol Number:
        012507

      • Principal Investigator:
        Matthew Matasar

      • Phase:
        Phase II

      • Scope:
        National

      • Applicable Disease Sites:
        Non-Hodgkin's Lymphoma

      • Therapies Involved:
        Chemotherapy multiple agents systemic

      • Drugs Involved:
        Lisocabtagene Maraleuce

      Read Inclusion & Exclusion Criteria

      Inclusion Criteria

      • Participant must be 18 years or older at the time of signing the informed consent form (ICF).
      • Histologically confirmed primary central nervous system (CNS) lymphoma (PCNSL) prior to screening, as assessed by local pathology.
      • Transplant-ineligible based on physician's assessment and meeting at least one of the following criteria: age ≥65 years or HCT-CI (Hematopoietic Cell Transplantation-specific Comorbidity Index) score ≥3.
      • Participant must be suitable, per investigator, to receive a high dose methotrexate (HD-MTX) based treatment regimen.
      • Prior to signing ICF, anti-cancer therapy for the treatment of PCNSL must only include standard of care regimens, with or without corticosteroids given for disease-related symptoms.
      • Prior to ICF signature, participant's disease must be sensitive to prior high-dose methotrexate-based regimens, as demonstrated by a complete response (CR, no remaining signs of PCNSL) or a partial response (PR, signs of PNCSL mostly gone) per Investigator's assessment, based on the International Primary CNS Lymphoma Collaborative Group (IPCG) criteria.
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
      • Individuals of childbearing potential (IOCBP) must have a negative highly sensitive pregnancy test within 24 hours prior to the start of study intervention.

      Exclusion Criteria

      • Participant has a diagnosis of secondary CNS lymphoma due to systemic disease.
      • Primary intraocular lymphoma (PIOL)/ Primary vitreoretinal lymphoma (PVRL) and isolated cerebrospinal fluid (CSF) disease.
      • Any significant medical condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she was to participate in the study based on investigator's judgement.
      • History of another primary malignancy that has not been in remission for ≥2 years.
      • Prior treatment with CAR T-cell or any other gene therapy product that utilizes human genome-editing technology.
      • History of or active human immunodeficiency virus (HIV).
      • Active hepatitis B or active hepatitis C.
      • Active autoimmune disease requiring immunosuppressive therapy.
      • 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.

    • 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.

      View All Details
      • Protocol Number:
        012108

      • Principal Investigator:
        Yun Kyoung Tiger

      • Phase:
        N/A

      • Scope:
        Local

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

      • Rutgers Cancer Institute
    • Open-Label Dose-Finding and Dose-Expansion Study to Evaluate the Safety, Expansion, Persistence, and Clinical Activity of UCART20x22 (in Subjects with Relapsed or Refractory B-Cell Non-Hodgkin s Lymphoma (B-NHL). - NCT04150497

      DOSE-FINDING PART Primary Objectives: To assess the safety and tolerability and determine the MTD and/or RP2D of UCART20x22 in subjects with R/R mature B-NHL. Secondary Objectives: - To assess the antitumor activity of UCART20x22 in subjects with R/R mature B-NHL. - To identify the optimal lymphodepletion (LD) regimen to evaluate in dose-expansion part cohort(s). - To measure the development of an immune response to alemtuzumab (CLLS52) at a central laboratory. - To evaluate the pharmacokinetics (PK) alemtuzumab (CLLS52) at a central laboratory. - To evaluate the pharmacodynamics (PD) of alemtuzumab (CLLS52) at a central laboratory. DOSE-EXPANSION PART Primary Objectives: - To assess the safety and tolerability of UCART20x22 and confirm the RP2D in subjects with R/R LBCL. Secondary Objectives: - To assess the antitumor activity of UCART20x22 in subjects with specific subtypes of R/R LBCL. - To measure the development of an immune response to alemtuzumab (CLLS52) at a central laboratory. - To evaluate the PK of alemtuzumab (CLLS52) at a central laboratory. - To evaluate the PD of alemtuzumab (CLLS52) at a central laboratory. DOSE-FINDING AND DOSE-EXPANSION PARTS Exploratory Objectives: - To characterize the expansion, trafficking, phenotype, and persistence of UCART20x22. - To assess cytokine, chemokine, and other soluble factor levels before and after UCART20x22 administration. - To measure the development of an immune response to UCART20x22. - To investigate the potential relationship between CD20 and CD22 expression levels on lymphoma cells and clinical outcome. - To investigate the role of the tumor microenvironment, CAR T-cell infiltration into the tumor, and clinical outcome. - To confirm the absence of RCL. - To assess minimal residual disease (MRD) negativity rate post UCART20x22 administration by a genomic assay.

      View All Details
      • Protocol Number:
        012208

      • Principal Investigator:
        Matthew Matasar

      • Phase:
        Phase I/II

      • Scope:
        National

      • Applicable Disease Sites:
        Non-Hodgkin's Lymphoma

      • Therapies Involved:
        Chemotherapy single agent systemic

      • Drugs Involved:
        UCART20x22

      Read Inclusion & Exclusion Criteria

      Inclusion Criteria:

      • B-ALL blast cells expressing CD22
      • Diagnosed with R/R B-ALL
      • Prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen

      Exclusion Criteria:

      • Prior cellular therapy or investigational cellular or gene therapy within 90 days priorto enrollment

      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.

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