NCT04196491

A Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple 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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, phase 1, single arm study intended to determine the optimal target dose and safety of bb2121 in subjects with HR (R-ISS Stage III per IMWG criteria) NDMM. Subjects should have received 3 Cycles of standard induction therapy prior to undergoing leukapheresis procedure to collect autologous mononuclear cells for manufacture of the drug product (bb2121). Following manufacture of the drug product, subjects will receive fourth cycle of induction therapy followed by lymphodepleting therapy with fludarabine and cyclophosphamide prior to bb2121 infusion. Maintenance therapy is recommended for all subjects who have received bb2121 infusion and should be initiated upon adequate bone marrow recovery or from 90-day post-bb2121 infusion, whichever is later.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	bb2121	CAR-T Cell Therapy
DRUG	Fludarabine	Lymphodepleting Chemotherapy
DRUG	Cyclophosphamide	Lymphodepleting Chemotherapy
DRUG	Lenalidomide	Maintenance Therapy

Timeline

• Start date: 2020-05-27
• Primary completion: 2023-06-07
• Completion: 2023-06-07
• First posted: 2019-12-12
• Last updated: 2023-08-23

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study