Clinical Trial 23203

• Overview

  Study Title:

  A Phase 1, Open-Label, Dose-Finding Study of BMS-986453, Dual Targeting BCMAxGPRCSD Chimeric Antigen Receptor T Cells, in Participants with Relapsed and/or Refractory Multiple Myeloma

  Summary:

  The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).

  Objective:

  Primary:  To evaluate the safety and tolerability of BMS-986453 in participants with RRMM  To determine the MTD and/or RP2D of BMS-986453 in participants with RRMM Secondary:  To assess/characterize the PK profile (cellular kinetics) of BMS-986453  To assess preliminary efficacy of BMS-986453 in participants with RRMM by IMWG Uniform Response Criteria Exploratory:  To evaluate the immunogenicity of BMS-986453  Assess the safety of BMS-986453 by testing for RCL  Characterize potential relationships between exploratory cytokine and chemokine biomarkers in blood and CAR T cellular kinetics, clinical response parameters, and clinical safety parameters  Assess depth and durability of response of BMS-986453 using minimal residual disease and additional PD markers  Assess the relationship between BCMA and/or GPRC5D expression on tumor cells and BMS-986453  Assess whether targeting dual antigens drives activation and/or exhaustion of CAR T cells  Assess the potential mechanisms of resistance and relapse to BMS-986453 including antigen loss and changes in the tumor microenvironment

• Treatments

  Therapies:

  Cell Therapy; Therapy (NOS)

  Medications:

  BMS-986453 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

• Inclusion Criteria

  Inclusion Criteria:
  • Participants must have a diagnosis of multiple myeloma with relapsed and/or refractory disease.
  • Participants must have confirmed progressive disease on or within 12 months (measured from the last dose) of completing treatment with the last anti-myeloma treatment regimen before study entry.
  • Participants in Part A and Part B Cohort 1 must have received at least 3 prior anti-myeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Participants must have adequate organ function.

• Exclusion Criteria

  Exclusion Criteria:
  • Participants must not have any known active or history of central nervous system (CNS) involvement of multiple myeloma.
  • Participants must not have active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis.
  • Participants must not have a history or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or cerebellar disease, or presence of clinically active psychosis.
  • Other criteria may apply.

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