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).
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.
Sequential
CB-011
Biological/VaccineCB-011 allogeneic CAR T cell therapy targeting BCMA Cyclophosphamide Chemotherapy for lymphodepletion Fludarabine Chemotherapy for lymphodepletion
(Part A) Number of patients with dose limiting toxicities (DLT)
Number of patients with DLTs during the 28 days following the first administration of CB-011.
(Part B) Overall Response Rate (ORR)
The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria.
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