A Study of TNB-383B in Participants With Relapsed or Refractory Multiple Myeloma

Study Identifier
TNB383B.0001
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2023-506993-11
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Study Details

Medical Condition
  • Blood Cancer - Multiple Myeloma
  • Study Drug
  • TNB-383B
  • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of TNB-383B, a BCMA x CD3 T-cell engaging bispecific antibody, in participants with relapsed or refractory MM who have received at least 3 prior lines of therapy. The study consists of 4 portions, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B), Monotherapy once every 4 weeks (Q4W) dosing (Arm E), Monotherapy once every 3 weeks (Q3W) dosing (Arm F). Arm A will evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of escalating doses of single-agent TNB-383B, administered Q3W, in approximately 73 participants. Once the maximum tolerated dose (MTD) or recommended phase 2 dose, (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 48 participants each. Dose A will be evaluated as a monotherapy Q4W, in Arm E to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 20 participants. Dose C will be evaluated as a monotherapy, in Arm F to further characterize the safety, tolerability, PK and PD profiles of the MTD/RP2D 2 dose expansion arms of 25 participants.

    Study Locations

    Location
    Status
    Location
    University of California San Francisco (UCSF) - Parnassus Heights /ID# 238680
    San Francisco, California, United States, 94143
    Status
    Not applicable
    Location
    Tulane University School of Medicine /ID# 242322
    New Orleans, Louisiana, United States, 70112
    Status
    Not applicable
    Location
    Mayo Clinic - Rochester /ID# 238683
    Rochester, Minnesota, United States, 55905-0001
    Status
    Not applicable
    Location
    Washington University-School of Medicine /ID# 238681
    St Louis, Missouri, United States, 63110
    Status
    Not applicable
    Location
    Mt Sinai /ID# 242317
    New York, New York, United States, 10029-6542
    Status
    Not applicable
    Location
    Memorial Sloan Kettering Cancer Center-Koch Center /ID# 244831
    New York, New York, United States, 10065-6007
    Status
    Not applicable
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