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.