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

Juno Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Alnuctamab; Drug: Iberdomide; Drug: Mezigdomide; Drug: Dexamethasone; Drug: Elranatamab; Drug: BMS-986393

Study type: Interventional

Funder types: Industry

Identifiers

NCT06121843

CA088-1005

Details and patient eligibility

About

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).

Enrollment: 187 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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187 participants in 5 patient groups

Arm A: BMS-986393 + Alnuctamab

Experimental group

Treatment:

Drug: BMS-986393

Drug: Alnuctamab

Arm B: BMS-986393 + Mezigdomide

Experimental group

Treatment:

Drug: BMS-986393

Drug: Mezigdomide

Arm C: BMS-986393 + Iberdomide

Experimental group

Treatment:

Drug: BMS-986393

Drug: Iberdomide

Arm D: BMS-986393 + Elranatamab

Experimental group

Treatment:

Drug: BMS-986393

Drug: Elranatamab

Arm E: BMS-986393 + Mezigdomide and Dexamethasone

Experimental group

Treatment:

Drug: BMS-986393

Drug: Dexamethasone

Drug: Mezigdomide