top of page
  • Recruiting

NCT04855136 : Phase 1/2 - Safety and Efficacy of bb2121 (Ide-cel) Combinations in MM (KarMMa-7)

Updated: Oct 3, 2022

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

Celgene

Bristol Myers Squibb


2seventybio

 

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

CART - BCMA : National Cancer Institute

Idecabtagene Vicleucel : National Cancer Institute

Idecabtagene Vicleucel : MedlinePlus Drug Information

Biological: BB2121

bb2121

CART


Patient Education: Idecabtagene Vicleucel (CART Cell Therapy) - Immunotherapy

 

Drug: CC-220

CC-220 - Iberdomide : National Cancer Institute

Cereblon (CRBN) E3 ligase modulatory compound (CELMoD)

 

Drug: BMS-986405

Crenigacestat (Code C171871)

gamma secretase inhibitor (GSI) JSMD194

Gamma-Secretase Inhibitor LY3039478 (Code C121535)

Gamma-Secretase Inhibitor LY3039478

JSMD194

LY 3039478

LY-3039478

LY3039478

 

Drug: Daratumumab

Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information


Drug: Dexamethasone

Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information


Drug: Pomalidomide

Pomalidomide: National Cancer Institute

Pomalidomide: MedlinePlus Drug Information


Drug: Bortezomib Bortezomib : National Cancer Institute

Bortezomib : MedlinePlus Drug Information

 

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

Click here for details

 

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

 

RELATED POSTS


NCT03361748: KarMMa - Phase 2 - Efficacy and Safety of bb2121 in refractory Myeloma (RRMM)

A Phase 2, Multicenter Study to Determine the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma

Click here for details


NCT03601078: KarMMa-2 - Phase 2 -Efficacy and Safety of bb2121 in relapsed & High Risk Myeloma (RRMM)

A Phase 2, Multicohort, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With Clinical High-Risk Multiple Myeloma (KarMMa-2)

Click here for details


NCT03651128: KarMMa-3 - Phase 3 - Study of bb2121 Vs Standard Regimens Refractory Myeloma (RRMM)

A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)

Click here for details


NCT04196491: KarMMa-4 - Phase 1 - Evaluate the Safety of bb2121 in High Risk, New Myeloma (NDMM)

A Phase 1, Open-label, Multicenter Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (KarMMa-4)

Click here for details






Posts Archive