NCT04855136 : Phase 1/2 - Safety and Efficacy of bb2121 (Ide-cel) Combinations in MM (KarMMa-7)
Updated: Oct 3, 2022
Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma (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.