CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
- Registration Number
- NCT05722418
- Lead Sponsor
- Caribou Biosciences, Inc.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.)
- 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.
- Eastern Cooperative Oncology Group performance status grade of 0 or 1.
- Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.
- Prior treatment with CAR-T cell therapy directed at any target.
- Autologous stem cell transplant within the last 6 weeks before lymphodepletion.
- Allogeneic stem cell transplant within 6 months before lymphodepletion.
- Known active or prior history of CNS involvement.
- Stroke or seizure within 6 months of signing ICF.
- Seropositive for or history of human immunodeficiency virus.
- Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion.
- Hepatitis B infection.
- Hepatitis C infection.
- Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description CB-011 CB-011 * Part A Escalation with CB-011 in ascending doses using a traditional 3+3 design. * Part B Expansion. Up to 30 participants will be enrolled to receive CB-011 at the RDE/MTD and/or RP2D determined in Plan A
- Primary Outcome Measures
Name Time Method (Part B) Overall Response Rate (ORR) 12 Months The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria.
(Part A) Number of patients with dose limiting toxicities (DLT) 28 days Number of patients with DLTs during the 28 days following the first administration of CB-011.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Hackensack Meridian John Theurer Cancer Center
đşđ¸Hackensack, New Jersey, United States
University of Alabama at Birmingham
đşđ¸Birmingham, Alabama, United States
CU Anschutz Medical Campus, Anshutz Cancer Pavillion
đşđ¸Aurora, Colorado, United States
Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics
đşđ¸Miami, Florida, United States
University of Kentucky/ Markey Cancer Center
đşđ¸Lexington, Kentucky, United States
Icahn School of Medicine at Mount Sinai
đşđ¸New York, New York, United States
Memorial Sloan Kettering Cancer Center
đşđ¸New York, New York, United States
Levine Cancer Institute
đşđ¸Charlotte, North Carolina, United States
Duke University Health System (DUHS)
đşđ¸Durham, North Carolina, United States
Oncology Hematology Care, Inc
đşđ¸Cincinnati, Ohio, United States
Cleveland Clinic
đşđ¸Cleveland, Ohio, United States
Sarah Cannon Research Institute
đşđ¸Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
đşđ¸Dallas, Texas, United States
Huntsman Cancer Institute, University of Utah
đşđ¸Salt Lake City, Utah, United States
Virginia Commonwealth University
đşđ¸Richmond, Virginia, United States
Froedtert and the Medical College of Wisconsin
đşđ¸Milwaukee, Wisconsin, United States