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)
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).
Arms & interventions
- BiologicalCB-011
CB-011 allogeneic CAR T cell therapy targeting BCMA Cyclophosphamide Chemotherapy for lymphodepletion Fludarabine Chemotherapy for lymphodepletion
Outcome measures
Primary
(Part A) Number of patients with dose limiting toxicities (DLT)
Number of patients with DLTs during the 28 days following the first administration of CB-011.
Time frame: 28 days
(Part B) Overall Response Rate (ORR)
The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria.
Time frame: 12 Months
Eligibility criteria
Study locations (16)
University of Alabama at Birmingham
Birmingham, Alabama, 35294
CU Anschutz Medical Campus, Anshutz Cancer Pavillion
Aurora, Colorado, 80045
Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics
Miami, Florida, 33136
University of Kentucky/ Markey Cancer Center
Lexington, Kentucky, 40536
Hackensack Meridian John Theurer Cancer Center
Hackensack, New Jersey, 07601
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Levine Cancer Institute
Charlotte, North Carolina, 28204
Duke University Health System (DUHS)
Durham, North Carolina, 27705
Oncology Hematology Care, Inc
Cincinnati, Ohio, 45236
Cleveland Clinic
Cleveland, Ohio, 44195
Tennessee Oncology
Nashville, Tennessee, 37203
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
Virginia Commonwealth University
Richmond, Virginia, 23235
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226