AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1)
18 Years and older, Male and Female
D8310C00001 (primary)
NCI-2023-06014
GC012F-CD19/BCMA-001
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.
Objectives
Phase 1b aims to evaluate the safety, tolerability, pharmacokinetic characteristics,
pharmacodynamic effect, and immunogenicity in subjects with relapsed/refractory multiple
myeloma and determine the recommended Phase 2 dose of AZD0120.
Phase II aims to evaluate the efficacy of AZD0120, and to further characterize the
safety, pharmacodynamic effects, immunogenicity, and changes in health-related quality of
life parameters in subjects with relapsed/refractory multiple myeloma.
Eligibility
- =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.
Treatment Sites in Georgia
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