Clinical Trial 23135

• Overview

  Study Title:

  A Phase 2, Open-Label, Multicenter Study of BMS-986393, a GPRC5D-directed CAR T Cell Therapy in Adult Participants with Relapsed or Refractory Multiple Myeloma (QUINTESSENTIAL)

  Objective:

  Primary: To evaluate the efficacy of BMS-986393 in participants with quadruple class exposed R/R MM having received at least 4 prior LOT. Secondary: -To further evaluate the efficacy of BMS-986393 in participants with quadruple class exposed R/R MM having received at least 4 prior LOT and 3 prior LOT. -To assess the safety of BMS-986393 among participants with R/R MM. -To assess additional efficacy parameters. -To assess the cellular kinetics of BMS-986393. -To assess key MM symptoms, functioning, and overall HRQoL. -To measure HCRU. Exploratory: -To evaluate the capacity of physiologic measurements captured by wearable biosensors to predict the onset of clinical events, including but not limited to CRS after BMS-986393. -To assess IMG of BMS-986393. -To assess the presence of RCL. -To assess MM antigen expression. -To assess soluble MM pharmacodynamic biomarker and soluble factors of immune response kinetics. -To molecularly profile CAR T cells, tumor, and microenvironment. -To assess patient-reported tolerability based on the PRO-CTCAE. -To assess the impact on health utility scores based on EQ-5D-5L, EORTC QLC-C30, and EORTC QLQ-MY20. -To validate the computerized algorithm to programmatically derive response based on IMWG criteria. -To assess relationship between PK parameters and selected clinical endpoints (eg, measures of toxicities, effectiveness, IMG, and/or biomarkers).

• Treatments

  Therapies:

  Cell Therapy; Chemotherapy (NOS)

  Medications:

  BMS-986393 (); Tocilizumab (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

• Inclusion Criteria

  Key Inclusion Criteria:
  • Participants at least 18 years of age or majority, inclusive, with documented diagnosis of MM as per International Myeloma Working Group (IMWG) criteria.
  • Participant must have received at least 4 classes of MM treatment (including an IMiD, PI, anti-CD38 mAb, and anti-BCMA therapy), and at least 3 prior LOT. Participants must have documented disease progression during or after their last anti-myeloma regimen (as per IMWG).
  • Participants must have measurable disease during screening.
  • Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Adherence to contraception requirements.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Participant with known active or history of central nervous system involvement with MM.
  • Participant has active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis.
  • Participant has received any prior therapy directed at GPRC5D or has received other prior treatment for MM without the required washout prior to leukapheresis.
  • Participant has inadequate organ function (per protocol definition).

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