A Phase Ib/II Study of AZD0120, Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants With Relapsed/Refractory Multiple Myeloma (DURGA-1)
Status: Recruiting
Location: See all (36) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This trial is a Phase 1b/2, open-label, multicenter study of AZD0120, a CD19/BCMA dual CAR T-cell therapy, in adult subjects with relapsed/refractory multiple myeloma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• ≥18 years of age at the time of consent.
• ECOG performance status of 0 or 1.
• Documented diagnosis of MM per IMWG diagnostic criteria.
• Participant must have received at least 3 prior lines of therapy, which include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody.
• Have documented evidence of progressive disease per IMWG criteria.
• Participant must have measurable disease at screening.
• Participant must have adequate bone marrow and organ function (hematological, hepatic and renal) demonstrated at screening.