CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
Purpose
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).
Condition
- Relapsed/Refractory Multiple Myeloma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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 |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
University of Kentucky/ Markey Cancer Center
Lexington, Kentucky 40536
Lexington, Kentucky 40536
More Details
- NCT ID
- NCT05722418
- Status
- Recruiting
- Sponsor
- Caribou Biosciences, Inc.