RecruitingInterventionalPhase 1

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

NCT ID: NCT06121843Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyLast updated: 2026-02-18

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).

Arms & interventions

DrugBMS-986393
Specified dose on specified days
DrugAlnuctamab
Specified dose on specified days
DrugMezigdomide
Specified dose on specified days
DrugIberdomide
Specified dose on specified days
DrugElranatamab
Specified dose on specified days

Outcome measures

Primary

Incidence of adverse events (AEs)
Time frame: Up to 2 years
Incidence of serious adverse events (SAEs)
Time frame: Up to 2 years
Incidence of adverse events of special interest (AESI)
Time frame: Up to 2 years
Incidence of AEs leading to discontinuation
Time frame: Up to 2 years
Number of Deaths
Time frame: Up to 2 years
Establish recommended Phase 2 dose (RP2D)
Time frame: Up to 2 years

Secondary

Overall response rate (ORR)
Time frame: Up to 2 years
Complete response rate (CRR)
Time frame: Up to 2 years
Very good partial response rate (VGPRR)
Time frame: Up to 2 years
Maximum observed concentration (Cmax) of arlocabtagene autoleucel
Time frame: Up to 2 years
Time of maximum observed concentration (tmax) of arlocabtagene autoleucel
Time frame: Up to 2 years
Area under the concentration-time curve from time 0 to 28 days [AUC (0-28D)] of arlocabtagene autoleucel
Time frame: Up to 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

Inclusion Criteria: * History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1) or at least 1 but not greater than 3 prior anti-myeloma treatment regimens (Part 2). * Measurable multiple myeloma (MM) as per International Myeloma Working Group (IMWG). * Eastern Cooperative Oncology Group performance status of 0-1. Exclusion Criteria: * Prior treatment with alnuctamab (Arm A), mezigdomide (Arm B), iberdomide (Arm C), elranatamab (Arm D) or BCMA-targeting therapy (Part 2 Arms A and D). * Prior treatment with GPRC5D-targeting therapies. * Other protocol-defined inclusion/exclusion criteria apply.