Study of bb2121 in Multiple Myeloma
Brief description of study
Study CRB-401 is a 2-part, non-randomized, open label, multi-site Phase 1 study of bb2121 in
adults with relapsed/refractory multiple myeloma (MM).
Clinical Study Identifier: NCT02658929
Detailed Study Description
Part A of the study will enroll adults with multiple myeloma using a 3+3 dose escalation
approach. An expansion cohort will be enrolled following dose selection.
Following consent, enrolled subjects will undergo a leukapheresis procedure to collect
autologous mononuclear cells for manufacture of investigational drug product (bb2121).
Following manufacture of the drug product, subjects will receive lymphodepletion prior to
bb2121 infusion. All subjects will then be followed for up to 24 months in Study CRB-401.
All subjects who complete the study, as well as those who withdraw from the study after
receiving bb2121 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 LTF-305 for up
to 15 years after their last bb2121 infusion, with a focus on long-term safety and efficacy.