NCT04855136

Safety and Efficacy of bb2121 (Ide-cel) Combinations in Multiple Myeloma

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)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	BB2121	CAR T Cell Therapy
DRUG	CC-220	Cereblon (CRBN) E3 ligase modulatory compound (CELMoD)
DRUG	BMS-986405	gamma secretase inhibitor (GSI)

Timeline

• Start date: 2021-06-01
• Primary completion: 2025-04-25
• Completion: 2025-04-25
• First posted: 2021-04-22
• Last updated: 2025-09-11

Locations

17 sites across 2 countries: United States, Spain

Regulatory

• FDA-regulated drug study