NCT03361748

Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

Detailed description

Anti-myeloma bridging treatment is allowed for disease control while bb2121 is being manufactured.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	bb2121	: bb2121 consists of autologous T lymphocytes transduced with an anti-BCMA02 CAR lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).

Timeline

• Start date: 2017-12-13
• Primary completion: 2023-12-20
• Completion: 2023-12-20
• First posted: 2017-12-05
• Last updated: 2025-05-23
• Results posted: 2025-05-23

Locations

48 sites across 8 countries: United States, Belgium, Canada, France, Germany, Italy, Japan, Spain

Regulatory

• FDA-regulated drug study