A Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM)
Status:
Recruiting
Trial end date:
2025-01-15
Target enrollment:
Participant gender:
Summary
This is a multicenter, open-label, phase 1, single arm study intended to determine the
optimal target dose and safety of bb2121 in subjects with HR (R-ISS Stage III per IMWG
criteria) NDMM. Subjects should have received 3 Cycles of standard induction therapy prior to
undergoing leukapheresis procedure to collect autologous mononuclear cells for manufacture of
the drug product (bb2121). Following manufacture of the drug product, subjects will receive
fourth cycle of induction therapy followed by lymphodepleting therapy with fludarabine and
cyclophosphamide prior to bb2121 infusion. Maintenance therapy is recommended for all
subjects who have received bb2121 infusion and should be initiated upon adequate bone marrow
recovery or from 90-day post-bb2121 infusion, whichever is later.