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 · tracked via the Priya Life Science USA tracker

Sponsor

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

Phase

Phase 1

Started

2024-02-22

Last updated

2026-07-16

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

BMS-986393 →AlnuctamabMezigdomide →Iberdomide →Elranatamab →Dexamethasone →

BMS-986393: Specified dose on specified days

Alnuctamab: Specified dose on specified days

Mezigdomide: Specified dose on specified days

Iberdomide: Specified dose on specified days

Elranatamab: Specified dose on specified days

Dexamethasone: Specified dose on specified days

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

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

Trial sites (19)

Facility	City	Region	Status
University of Alabama at Birmingham	Birmingham	Alabama	Recruiting
Mayo Clinic in Arizona - Phoenix	Phoenix	Arizona	Recruiting
City of Hope Comprehensive Cancer Center	Duarte	California	Recruiting
Mayo Clinic in Florida	Jacksonville	Florida	Recruiting
Northside Hospital	Atlanta	Georgia	Recruiting
Beth Israel Deaconess Medical Center	Boston	Massachusetts	Recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	Recruiting
Mayo Clinic in Rochester, Minnesota	Rochester	Minnesota	Recruiting
University Of Nebraska Medical Center	Omaha	Nebraska	Recruiting
John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey	Recruiting
Roswell Park Cancer Institute	Buffalo	New York	Recruiting
Laura and Isaac Perlmutter Cancer Center	New York	New York	Recruiting
Local Institution - 0009	New York	New York	Completed
Memorial Sloan Kettering Cancer Center	New York	New York	Recruiting
Local Institution - 0023	Pittsburgh	Pennsylvania	Withdrawn
Tennessee Oncology	Nashville	Tennessee	Recruiting
University of Texas MD Anderson Cancer Center	Houston	Texas	Recruiting
Arthur J.E. Child Comprehensive Cancer Centre	Calgary	Alberta	Recruiting
Princess Margaret Cancer Centre	Toronto	Ontario	Recruiting

More Juno Therapeutics, Inc., a Bristol-Myers Squibb Company trials in the USA

Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE) Starting soon

Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma Recruiting

A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma (QUINTESSENTIAL-2) Recruiting

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

A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases Recruiting

Other trials for the same condition

Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies Recruiting

Safety, Efficacy, and Pharmacokinetics of Continuous Subcutaneous Lenalidomide in Multiple Myeloma (MM) Recruiting

Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Second Primary Malignancy Recruiting

A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma Recruiting

A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06121843 on ClinicalTrials.gov ↗ ← All trials in the USA