A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma

NCT06153251
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
187
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Lead sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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Start date
2024-01-23
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Number of sites
19
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Summary
The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).
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Short title
A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma
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Official title
A Phase 1, Open-Label, Dose-Finding Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2030-05-02
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First posted
2023-12-01
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Registry last updated
2026-03-18
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Primary completion date
2030-05-02
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Start date
2024-01-23
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Participants
187
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Participant count basis
Estimated
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Planned participants
187
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Protocol amendments
2
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Number of sites
19
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06153251
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ClinicalTrials.gov ID
NCT06153251
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of participants with treatment-emergent adverse events (AEs)

    Timeframe: Up to 4 years

  2. Number of participants with serious adverse events (SAEs)

    Timeframe: Up to 4 years

  3. Number of participants with AEs leading to discontinuation

    Timeframe: Up to 4 years

  4. Number of participants with AEs leading to death

    Timeframe: Up to 4 years

  5. Number of participants with dose-limiting toxicities (DLTs)

    Timeframe: Up to 4 years

  1. Maximum observed concentration (Cmax)

    Timeframe: Up to 4 years

  2. Time of maximum observed concentration (Tmax)

    Timeframe: Up to 4 years

  3. Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))

    Timeframe: Up to 4 years

  4. Overall response rate (ORR)

    Timeframe: Up to 4 years

  5. Complete response rate (CRR)

    Timeframe: Up to 4 years

  6. Number of participants with very good partial response (VGPR) or better

    Timeframe: Up to 4 years

  7. Progression-free survival (PFS)

    Timeframe: Up to 4 years

  8. Overall survival (OS)

    Timeframe: Up to 4 years

  9. Time to response (TTR)

    Timeframe: Up to 4 years

  10. Time to complete response (TTCR)

    Timeframe: Up to 4 years

  11. Duration of response (DOR)

    Timeframe: Up to 4 years

  12. Duration of complete response (DOCR)

    Timeframe: Up to 4 years

  13. Persistence of BMS-986453 in peripheral blood

    Timeframe: Up to 4 years

    Defined as a transgene count greater than or equal to the lower limit of detection (LLOD)

  14. Expansion rate

    Timeframe: Up to 4 years

    Defined as Cmax divided by Tmax

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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 and in Part B Cohort 2 must have relapsed/refractory multiple myeloma and received previous antimyeloma therapy, including a proteasome inhibitor and an immunomodulatory agent.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Participants must have adequate organ function.

  • 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 protocol-defined inclusion/exclusion criteria apply.
Sources for eligibility
clinicaltrials.gov

  • University of Alabama at BirminghamBirmingham, United StatesRecruiting
  • City of Hope Comprehensive Cancer CenterDuarte, United StatesRecruiting
  • UCSF Helen Diller Medical Center at Parnassus HeightsSan Francisco, United StatesRecruiting
  • Stanford University Medical CenterStanford, United StatesRecruiting
  • Colorado Blood Cancer InstituteDenver, United StatesRecruiting
  • Yale Cancer CenterNew Haven, United StatesRecruiting
  • Moffitt Cancer CenterTampa, United StatesRecruiting
  • Dana-Farber Cancer InstituteBoston, United StatesRecruiting
  • Icahn School of Medicine at Mount SinaiNew York, United StatesRecruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • Local Institution - 0008Nashville, United StatesNot yet recruiting
  • Tennessee OncologyNashville, United StatesRecruiting
  • Swedish Medical CenterSeattle, United StatesRecruiting
  • Hôpital Saint-LouisParis, FranceRecruiting
  • Universitaetsklinikum KoelnCologne, GermanyRecruiting
  • Universitaetsklinikum HeidelbergHeidelberg, GermanyRecruiting
  • Universitaetsklinikum WuerzburgWürzburg, GermanyRecruiting
  • Clinica Universidad de NavarraPamplona, SpainRecruiting
  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de SalamancaSalamanca, SpainRecruiting
Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-506003-26-00
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (14)