A Phase 1, Multicenter, Open-Label Study of CB-011, a CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (CaMMouflage Trial)
Caribou Biosciences, Inc.
Summary
This is a Phase 1 study to evaluate the safety of CB-011 (the study treatment), an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets the B cell maturation antigen (BCMA), to determine the best dose of CB-011, and to assess the effectiveness of CB-011 in treating multiple myeloma that has come back (relapsed) or that is no longer responding to other treatment (refractory).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.) 2. Received at least 3 prior MM treatment lines of therapy which must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody as part of a prior line of therapy, either in monotherapy or in combination. 3. Eastern Cooperative Oncology Group performance status grade of 0 or 1. 4. Adequate hematologic, renal, hepatic, pulmonary, and cardiac function. Exclusion Criteria: 1. Prior treatment wi…
Interventions
- BiologicalCB-011
CB-011 allogeneic CAR T cell therapy targeting BCMA Cyclophosphamide Chemotherapy for lymphodepletion Fludarabine Chemotherapy for lymphodepletion
Locations (16)
- University of Alabama at BirminghamBirmingham, Alabama
- CU Anschutz Medical Campus, Anshutz Cancer PavillionAurora, Colorado
- Sylvester Comprehensive Cancer Center, University of Miami Hospital and ClinicsMiami, Florida
- University of Kentucky/ Markey Cancer CenterLexington, Kentucky
- Hackensack Meridian John Theurer Cancer CenterHackensack, New Jersey
- Icahn School of Medicine at Mount SinaiNew York, New York