A Phase 1 Study of bb21217, an Anti-BCMA CAR T Cell Drug Product, in Relapsed and / or Refractory Multiple Myeloma
18 Years and older, Male and Female
Study CRB-402 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb21217 in adults with relapsed / refractory multiple myeloma (MM).
Part A of the study will be Dose Escalation followed by Part B, an expansion cohort.
Following consent, enrolled subjects will undergo a leukapheresis procedure to collect
autologous mononuclear cells for manufacture of investigational drug product (bb21217).
Following manufacture of the drug product, subjects will receive lymphodepletion prior to
bb21217 infusion. All subjects will then be followed for up to 24 months in Study CRB-402.
All subjects who complete the study, as well as those who withdraw from the study after
receiving bb21217 for reasons other than death or meeting the early termination criteria,
will be asked to continue to undergo long-term follow-up in a companion study.