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TERMINATED
NCT04855136
PHASE1

Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma

Sponsor: Celgene

View on ClinicalTrials.gov

Summary

This is a global, open-label, multi-arm, multi-cohort, multi-center, phase 1/2 study to determine the safety, tolerability, efficacy, PK of bb2121 in combination with other therapies in adult subjects with R/RMM. The following combinations will be * Arm A will test bb2121 in combination with CC-220 (± low-dose dexamethasone) * Arm B will test bb2121 in combination with BMS-986405 (JSMD194) Combination agents being tested may be administered before, concurrently with and/or following (ie, maintenance) bb2121 infusion. The study will consist of 2 parts: dose finding (Phase 1) and dose expansion (Phase 2). Dose expansion may occur in one or more arms.

Official title: An Exploratory Phase 1/2 Trial to Determine Recommended Phase 2 Dose (RP2D), Safety and Preliminary Efficacy of bb2121 (Ide-cel) Combinations in Subjects With Relapsed/Refractory Multiple Myeloma (KarMMa-7)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

21

Start Date

2021-06-01

Completion Date

2025-04-25

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

BIOLOGICAL

BB2121

CAR T Cell Therapy

DRUG

CC-220

Cereblon (CRBN) E3 ligase modulatory compound (CELMoD)

DRUG

BMS-986405

gamma secretase inhibitor (GSI)

Locations (17)

Local Institution - 117

Birmingham, Alabama, United States

Local Institution - 113

San Francisco, California, United States

Local Institution - 101

Jacksonville, Florida, United States

Local Institution - 104

Atlanta, Georgia, United States

Local Institution - 120

Atlanta, Georgia, United States

Local Institution - 114

Chicago, Illinois, United States

Local Institution - 108

Boston, Massachusetts, United States

Local Institution - 124

Boston, Massachusetts, United States

Local Institution - 109

Hackensack, New Jersey, United States

New York University Langone

New York, New York, United States

Local Institution - 110

New York, New York, United States

Local Institution - 111

Charlotte, North Carolina, United States

Local Institution - 118

Philadelphia, Pennsylvania, United States

Local Institution - 103

Nashville, Tennessee, United States

Local Institution - 107

Houston, Texas, United States

Local Institution - 201

Pamplona, Spain

Local Institution - 202

Salamanca, Spain