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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 bb2121

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


 

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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