- Active, not recruiting
NCT04855136 : Phase 1/2 - Safety and Efficacy of bb2121 (Ide-cel) Combinations in MM (KarMMa-7)
Updated: Feb 5
bb2121
Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma (KarMMa-7)
KarMMa-7
Relapsed & Refractory Multiple Myeloma
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)
Arm C will test bb2121 in combination with one of the following standard triplet regimens:
1) Daratumumab (DARA) in combination with pomalidomide (POM) and low-dose dexamethasone (DPd)
2) Pomalidomide (POM) in combination with bortezomib (BTZ) and low-dose dexamethasone (PVd)
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.
Sponsor
Bristol Myers Squibb
ClinicalTrials.gov Identifier: NCT04855136
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)
First Posted : April 22, 2021
Click here for details on Clinicaltrials.gov
Idecabtagene Vicleucel
Biological: BB2121
bb2121
CART
Drug: CC-220
Cereblon (CRBN) E3 ligase modulatory compound (CELMoD)
Drug: BMS-986405
gamma secretase inhibitor (GSI) JSMD194
Gamma-Secretase Inhibitor LY3039478 (Code C121535)
Gamma-Secretase Inhibitor LY3039478
JSMD194
LY 3039478
LY-3039478
LY3039478
Drug: Daratumumab
Drug: Dexamethasone
Drug: Pomalidomide
Drug: Bortezomib Bortezomib : National Cancer Institute
704.CELLULAR IMMUNOTHERAPIES: CLINICAL| NOVEMBER 5, 2021
KarMMa-7, a Phase 1/2, Dose-Finding and Dose-Expansion Study of Combination Therapies with Idecabtagene Vicleucel (ide-cel, bb2121), a BCMA-Directed CAR T Cell Therapy for Relapsed/Refractory Multiple Myeloma (RRMM)
Blood (2021) 138 (Supplement 1): 4830
Mayo Clinic - Jacksonville
Northside Hospital, Inc Atlanta
Columbia University Medical Center, New York
Sarah Cannon Research Institute Center for Blood Cancers Nashville, Tennessee
The University of Texas - MD Anderson Cancer Center
Clinica Universidad de Navarra Pamplona, Spain
Universitario de Salamanca - Hospital Clinico Salamanca, Spain
Locations
United States, Florida
United States, Georgia
United States, New York
United States, Tennessee
United States, Texas
Europe
Spain
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