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

Phase 1

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: BMS-986393; Drug: Alnuctamab; Drug: Mezigdomide; Drug: Iberdomide; Drug: Elranatamab

• Registration Number: NCT06121843
• Lead Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-08
• Study Start: 2024-02-22
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-25
• Last Update Posted: 2025-10-01
• Primary Completion: 2028-08-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

• History of relapsed and/or refractory multiple myeloma (RRMM) treated with at least 3 (Part 1 and Part 2) or at least 1 but not greater than 3 prior anti-myeloma treatment regimens (Part 2).
• Measurable multiple myeloma (MM).
• 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.

Note: Other protocol-defined inclusion/exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm A: BMS-986393 + Alnuctamab	BMS-986393	-
Arm A: BMS-986393 + Alnuctamab	Alnuctamab	-
Arm B: BMS-986393 + Mezigdomide	BMS-986393	-
Arm B: BMS-986393 + Mezigdomide	Mezigdomide	-
Arm C: BMS-986393 + Iberdomide	BMS-986393	-
Arm C: BMS-986393 + Iberdomide	Iberdomide	-
Arm D: BMS-986393 + Elranatamab	BMS-986393	-
Arm D: BMS-986393 + Elranatamab	Elranatamab	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (19)

Tennessee Oncology; 🇺🇸 Nashville, Tennessee, United States

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic in Arizona - Phoenix; 🇺🇸 Phoenix, Arizona, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Northside Hospital; 🇺🇸 Atlanta, Georgia, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Mayo Clinic in Rochester, Minnesota; 🇺🇸 Rochester, Minnesota, United States

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