CRISPR-edited CAR-T cell therapy for multiple myeloma
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)
This study is testing a new CAR-T cell therapy called CB-011 to see if it can safely help people with relapsed or hard-to-treat multiple myeloma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Caribou Biosciences, Inc. Industry-sponsored |
| Drugs / interventions | CAR-T, chimeric antigen receptor |
| Locations | 16 sites (Birmingham, Alabama and 15 other locations) |
| Trial ID | NCT05722418 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study evaluates the safety and effectiveness of CB-011, an allogeneic CAR-T cell therapy targeting the B cell maturation antigen (BCMA), in patients with relapsed or refractory multiple myeloma. The study aims to determine the optimal dose of CB-011 while assessing its potential to treat patients whose disease has returned or is unresponsive to previous therapies. Participants must have measurable disease and a history of multiple prior treatments, including specific drug classes. The trial will also monitor participants for any adverse effects associated with the therapy.
Who should consider this trial
Good fit: Ideal candidates are adults with relapsed or refractory multiple myeloma who have undergone at least three prior lines of treatment.
Not a fit: Patients who have previously received CAR-T cell therapy or have certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat multiple myeloma.
How similar studies have performed: Other studies using CAR-T cell therapies have shown promising results, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 with CAR-T cell therapy directed at any target. 2. Autologous stem cell transplant within the last 6 weeks before lymphodepletion. 3. Allogeneic stem cell transplant within 6 months before lymphodepletion. 4. Known active or prior history of CNS involvement. 5. Stroke or seizure within 6 months of signing ICF. 6. Seropositive for or history of human immunodeficiency virus. 7. Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion. 8. Hepatitis B infection. 9. Hepatitis C infection. 10. Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.
Where this trial is running
Birmingham, Alabama and 15 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- CU Anschutz Medical Campus, Anshutz Cancer Pavillion — Aurora, Colorado, United States (Recruiting)
- Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics — Miami, Florida, United States (Recruiting)
- University of Kentucky/ Markey Cancer Center — Lexington, Kentucky, United States (Recruiting)
- Hackensack Meridian John Theurer Cancer Center — Hackensack, New Jersey, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Levine Cancer Institute — Charlotte, North Carolina, United States (Recruiting)
- Duke University Health System (DUHS) — Durham, North Carolina, United States (Recruiting)
- Oncology Hematology Care, Inc — Cincinnati, Ohio, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Tennessee Oncology — Nashville, Tennessee, United States (Recruiting)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- Huntsman Cancer Institute, University of Utah — Salt Lake City, Utah, United States (Recruiting)
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
- Froedtert and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Caribou Biosciences
- Email: clinicaltrials@cariboubio.com
- Phone: 510-982-6030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.