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CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
Trial Status: active
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).
Inclusion Criteria
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.
Exclusion Criteria
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.
Additional locations may be listed on ClinicalTrials.gov for NCT05722418.
