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).
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.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of bb2121 in BCMA-Expressing Multiple Myeloma
Actual Study Start Date: January 31, 2016
Estimated Primary Completion Date: December 31, 2018
Estimated Study Completion Date: February 28, 2020
- Experimental: bb2121
|Date last updated at source||2018-04-10|
|Study start date||2016-01-31|
|Estimated primary completion date||2018-12-31|