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Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma
Sponsor: Celgene
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
Conditions
Interventions
BB2121
CAR T Cell Therapy
CC-220
Cereblon (CRBN) E3 ligase modulatory compound (CELMoD)
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