A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma

NCT06121843
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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
2024-02-22
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Number of sites
19
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Summary
The purpose of this study is to establish a safe and tolerable dose of arlocabtagene autoleucel (BMS-986393) in combinations with alnuctamab, mezigdomide, iberdomide, and elranatamab in participants with relapsed and/or refractory multiple myeloma (RRMM).
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Short title
A Study to Evaluate the Safety, Effectiveness and Tolerable Dose of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma
clinicaltrials.gov
Official title
A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of Arlocabtagene Autoleucel (BMS-986393) in Novel Combinations in Participants With Relapsed and/or Refractory Multiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational Component
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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
2028-08-01
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First posted
2023-11-08
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Registry last updated
2026-07-16
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Primary completion date
2028-08-01
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Start date
2024-02-22
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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
3
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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
NCT06121843
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ClinicalTrials.gov ID
NCT06121843
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Incidence of adverse events (AEs)

    Timeframe: Up to 2 years

  2. Incidence of serious adverse events (SAEs)

    Timeframe: Up to 2 years

  3. Incidence of adverse events of special interest (AESI)

    Timeframe: Up to 2 years

  4. Incidence of AEs leading to discontinuation

    Timeframe: Up to 2 years

  5. Number of Deaths

    Timeframe: Up to 2 years

  6. Establish recommended Phase 2 dose (RP2D)

    Timeframe: Up to 2 years

  1. Overall response rate (ORR)

    Timeframe: Up to 2 years

  2. Complete response rate (CRR)

    Timeframe: Up to 2 years

  3. Very good partial response rate (VGPRR)

    Timeframe: Up to 2 years

  4. Maximum observed concentration (Cmax) of arlocabtagene autoleucel

    Timeframe: Up to 2 years

  5. Time of maximum observed concentration (tmax) of arlocabtagene autoleucel

    Timeframe: Up to 2 years

  6. Area under the concentration-time curve from time 0 to 28 days [AUC (0-28D)] of arlocabtagene autoleucel

    Timeframe: Up to 2 years

Sources for outcomes
clinicaltrials.gov

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

  • History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1), history of RRMM or at least 1 but not greater than 3 prior anti-myeloma treatment (PAMT) regimens (Part 2, Arms A, B, C, and D); history of quadruple class exposed RRMM having received BCMA TCE as the most recent line of therapy (Part 2, Arm E).
  • Measurable multiple myeloma (MM) as per International Myeloma Working Group (IMWG).
  • Eastern Cooperative Oncology Group performance status of 0-1.
  • Adherence to contraception requirements.

  • Prior treatment with alnuctamab (Arm A), mezigdomide (Arms B and E), iberdomide (Arm C), elranatamab (Arm D) or BCMA-targeting therapy (Part 2 Arms A and D).
  • Prior treatment with GPRC5D-targeting therapies as of Protocol Amendment 02 (Part 1 and Part 2).
  • Other protocol-defined inclusion/exclusion criteria apply.
Sources for eligibility
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  • University of Alabama at BirminghamBirmingham, United StatesRecruiting
  • Mayo Clinic in Arizona - PhoenixPhoenix, United StatesRecruiting
  • City of Hope Comprehensive Cancer CenterDuarte, United StatesRecruiting
  • Mayo Clinic in FloridaJacksonville, United StatesRecruiting
  • Northside HospitalAtlanta, United StatesRecruiting
  • Beth Israel Deaconess Medical CenterBoston, United StatesRecruiting
  • Dana-Farber Cancer InstituteBoston, United StatesRecruiting
  • Mayo Clinic in Rochester, MinnesotaRochester, United StatesRecruiting
  • University Of Nebraska Medical CenterOmaha, United StatesRecruiting
  • John Theurer Cancer Center at Hackensack University Medical CenterHackensack, United StatesRecruiting
  • Roswell Park Cancer InstituteBuffalo, United StatesRecruiting
  • Laura and Isaac Perlmutter Cancer CenterNew York, United StatesRecruiting
  • Local Institution - 0009New York, United StatesCompleted
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • Local Institution - 0023Pittsburgh, United StatesWithdrawn
  • Tennessee OncologyNashville, United StatesRecruiting
  • University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting
  • Arthur J.E. Child Comprehensive Cancer CentreCalgary, CanadaRecruiting
  • Princess Margaret Cancer CentreToronto, CanadaRecruiting
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (6)

Lead sponsors (1)

Conditions (1)

Targets (5)