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Safety and Efficacy of AZD0120, a BCMA/CD19 Dual-Targeting CAR T-cell Therapy, in relapsed/refractory Multiple Myeloma: Preliminary Results from the DURGA-1 phase 1b/2 Study
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Safety and Efficacy of AZD0120, a BCMA/CD19 Dual-Targeting CAR T-cell Therapy, in relapsed/refractory Multiple Myeloma: Preliminary Results from the DURGA-1 phase 1b/2 Study

Shambavi Richard, Mahmoud Gaballa, Tara Gregory, Saurabh Chhabra, Larry D. Anderson, Luciano J. Costa, Caitlin Costello, Scott R. Goldsmith, Doris K. Hansen, Sridevi Rajeeve, …
Transplantation and cellular therapy, Vol.32(2 Supplement), pp.S33-S33
02/2026
DOI: 10.1016/j.jtct.2025.12.054

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Abstract

Introduction Multiple myeloma (MM) accounts for nearly 20% of all hematologic cancers in the US and remains a substantial clinical burden. While BCMA-directed CAR T-cell therapy has improved outcomes, challenges persist. AZD0120 (formerly GC012F) is a first-in-class autologous BCMA/CD19 dual-targeting CAR T-cell therapy using the FasTCAR rapid manufacturing platform. We report preliminary phase 1b results from DURGA-1, an ongoing phase 1b/2 trial evaluating AZD0120 in patients (pts) with relapsed/refractory (RR) MM. Methods This open-label, single-arm, US-based, multicenter study (NCT05850234) evaluated the safety of 2 dose levels (DLs) of AZD0120. Eligible pts were ≥18 y with RRMM (3+ prior lines of therapy [pLOT]), ECOG PS 0–1, and evidence of progressive disease. Prior BCMA-directed therapy ≥6 mo with best response of partial response or better was permitted. Pts received a single infusion of AZD0120 (DL1: 1×105 cells/kg; DL2: 3×105 cells/kg). Phase 1b primary objectives: safety/tolerability, RP2D determination; secondary objectives: efficacy, cellular kinetics (CK), pharmacodynamics. Results At data cutoff (DCO; 18 July 2025), 25 pts received AZD0120 (n=12 DL1; n=13 DL2). Median age was 64 y (range 44–78), median pLOT was 4 (range 3–7), 72% were triple-class refractory, 20% had prior BCMA CAR T-cell therapy, and 28% had high-risk cytogenetic features. Median time from apheresis to infusion was 28 d (range 19–44); 5 pts received bridging therapy. Median follow-up was 1.4 mo (range 0–19.3). No dose-limiting toxicities were reported. Most common treatment-emergent AEs (any grade) were CRS (64%), neutrophil count decreased (56%), and anemia (32%). CRS was reported in 75% (DL1) and 54% (DL2) of pts, with no cases grade ≥3. Median time to CRS onset (DL1/DL2) was 9 d (range 2–11); 12 pts (48%) received tocilizumab to manage CRS. No deaths or cases of ICANSEC-colitis, or secondary primary malignancies were reported. For efficacy-evaluable pts (n=15), overall response rate was 100% and complete response rate was 33%; median time to response was 0.9 mo for both DLs (range 0.6–1.9). All pts evaluable for minimal residual disease (MRD; n=5 DL1; n=3 DL2; DCO 1 July 2025) were MRD negative by next-generation sequencing (10-5 sensitivity). Three pts in DL1 with ≥12 mo follow-up maintained MRD negativity. CK analysis from 16 evaluable pts (DCO 12 June 2025) demonstrated median Tmax of 13 d post-infusion and median persistence of 42 d (range 13–273). Updated clinical data will be presented. Conclusion Preliminary phase 1b results demonstrated AZD0120 was well tolerated, with a low incidence of serious AEs, no grade ≥3 CRS, and no ICANS. FasTCAR-manufactured AZD0120 had controlled in vivo expansion leading to a predictable safety profile. A single infusion of AZD0120 achieved early, deep responses with 100% MRD negativity in triple-class‒exposed pts with RRMM.

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