CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma

Launched by CARIBOU BIOSCIENCES, INC. · Feb 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CB-011 for patients with relapsed or refractory multiple myeloma, which means their cancer has returned or has not responded to previous therapies. CB-011 is a type of CAR-T cell therapy that is designed to target a specific protein on cancer cells called BCMA. The main goals of the trial are to see how safe this treatment is, find the best dose, and evaluate how well it works in treating this type of cancer.

To be eligible for this study, participants should have been diagnosed with relapsed or refractory multiple myeloma and must have already tried at least three prior treatments, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Participants should also be in relatively good health, as measured by their ability to perform daily activities. Those who have had certain previous treatments, such as CAR-T therapy or stem cell transplants, or have specific health issues may not qualify. If you decide to participate, you will be monitored closely for safety and effectiveness as you receive this new treatment.

Gender

ALL

Eligibility 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.