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

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06121843

Enrollment

147

Registered

2023-11-08

Start date

2024-02-22

Completion date

2028-08-01

Last updated

2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

BMS-986393, Relapsed Multiple Myeloma, Refractory Multiple Myeloma, First-in-human, Alnuctamab, Mezigdomide, Iberdomide, CC-95266, GPRC5D, GPRC5D CAR T, Cell Therapy, CAR T cell therapy, Combination therapy, elranatamab, arlocabtagene autoleucel, arlo-cel

Brief 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).

Interventions

Specified dose on specified days

Specified dose on specified days

DRUGMezigdomide

Specified dose on specified days

DRUGIberdomide

Specified dose on specified days

DRUGElranatamab

Specified dose on specified days

Sponsors

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Lead SponsorINDUSTRY

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy 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/

Design outcomes

Primary

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

Secondary

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

Countries

Canada, United States

Contacts

CONTACTBMS Study Connect Contact Center www.BMSStudyConnect.com

Clinical.Trials@bms.com855-907-3286

CONTACTFirst line of the email MUST contain NCT # and Site #.

STUDY_DIRECTORBristol-Myers Squibb

Bristol-Myers Squibb

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026