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A Phase 1 Study of bb21217, an Anti-BCMA CAR T Cell Drug Product, in Relapsed and / or Refractory Multiple Myeloma

Status
Active
Cancer Type
Lymphoma
Multiple Myeloma
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03274219
Protocol IDs
CRB-402 (primary)
NCI-2017-01861
Study Sponsor
Bluebird Bio

Summary

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).

Objectives

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.
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