AZD0120 in Relapsed/Refractory Multiple Myeloma (DURGA-1) DURGA-1

What's the purpose of this trial?

This trial is a phase 1b/2, open-label, multicenter study of GC012F (AZD0120), a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory Multiple Myeloma.

This trial is currently open and accepting patients.

What will happen during the trial?

For Phase Ib It aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect, immunogenicity in subjects with relapsed/ refractory Multiple Myeloma, and determine the recommended Phase 2 dose of GC012F.

For Phase 2, it aims to evaluate the efficacy, pharmacokinetic characteristics, pharmacodynamic effect, and immunogenicity, changes from baseline for subject-reported health-related quality of life, overall health status in subjects with relapsed/ refractory Multiple Myeloma.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • ≥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.

Exclusion Criteria :

  • Participant has a history of significant toxicity during prior CAR T-cell therapy and T-cell engaging therapy.
  • Participant has a history of a prior non-hematologic malignancy, unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years. Some exceptions may apply.
  • Participant has significant cardiac, neurological, or psychiatric conditions.

  • Any other significant medical conditions such as:

    • Serious active or uncontrolled infection
    • Active autoimmune disease or a history of autoimmune disease within 2 years
    • Active plasma cell leukemia at the time of screening
    • Clinical evidence of dementia or altered mental status, or stroke, intracranial haemorrhage, or seizure within 6 months before signing informed consent form (ICF).
  • Known active or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of MM.

Other protocol-defined Inclusion/Exclusion criteria apply.

Additional Trial Information

Phase 1/2

Enrollment: 182 patients (estimated)

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Published Results

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

December 09, 2025

Results: As of data cutoff (DCO) on 18 July 2025, a total of 25 pts received infusion of AZD0120 (n=12 DL1; n=13 DL2). The 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, 4% had prior teclistamab, 28% had high-risk cytogenetic features [del(13q), del(17p13), t(4;14), t(14;16), amp(1q)], and 8% had extramedullary plasmacytomas. The median time from apheresis to release was 14 d (range 10–30). Median time from apheresis to infusion was 28 d (range 19–44) with 5 pts receiving bridging therapy. Median follow-up was 1.4 mo (range 0–19.3). No dose-limiting toxicities were reported for either dose. The most common treatment-emergent AEs (TEAEs, any grade) were CRS (64%), neutrophil count decreased (56%), and anemia (32%). The most common grade ≥3 TEAEs were neutrophil count decreased (52%), lymphocyte count decreased (32%), and white blood cell count decreased (32%). CRS was reported in 75% of pts at DL1 (all grade 1) and 54% at DL2 (46% grade 1; 8% grade 2), with no cases of grade ≥3 CRS. Median time to CRS onset (DL1/DL2) was 9 d (range 2–11), with a median duration of 2 d (range 1–4); 12 pts (48%) received tocilizumab for CRS management and 12% received dexamethasone. No cases of ICANS, related non-ICANS neurotoxicity, IEC-colitis, or secondary primary malignancies have been reported. There have been no deaths. For efficacy-evaluable patients (n=15), ORR was 100% (33% sCR, 47% VGPR, 20% PR). CR rates in evaluable pts were 30% in DL1 (n=10) and 40% in DL2 (n=5); median time to response was 0.9 mo for both DLs (range 0.9–1.9 DL1; 0.6–1.8 DL2). All MRD-evaluable pts (n=5 DL1; n=3 DL2; DCO 01 July 2025) were MRD-negative by NGS at a sensitivity of 10 -5 . Three pts in DL1 with ≥12 mo follow-up maintained MRD negativity. Consistent with robust in vivo expansion, CK analysis from 16 evaluable pts (DCO 12 June 2025) demonstrated a median Tmax of 13 d post-infusion with a median Cmax of 85,266 copies/mg gDNA. Median persistence was 42 d (range 13–273). Updated clinical data with additional follow-up 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 expected in vivo expansion, which may have resulted in the predictable CRS profile. A single infusion of AZD0120 achieved early, deep responses with 100% MRD negativity from 4L+ triple-class‒exposed pts with RRMM.

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Trial Links

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Trial Locations

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Alabama

University of Alabama at Birmingham O'Neal Comprehensive Cancer Center

Birmingham, AL

Open and Accepting

Arizona

Mayo Clinic (Arizona)

Phoenix, AZ

Open and Accepting

California

UCSF Helen Diller Comprehensive Cancer Center University of California San Francisco

San Francisco, CA

Open and Accepting

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

Moores Cancer Center University of California UC San Diego Health

La Jolla, CA

Open and Accepting

UCLA Medical Center of Hematology/Oncology

Los Angeles, CA

Open and Accepting

Colorado

University of Colorado Cancer Center Anschutz Cancer Pavilion

Aurora, CO

Open and Accepting

Colorado Blood Cancer Institute Sarah Cannon at Presbyterian/St. Luke's Medical Center (HealthONE)

Denver, CO

Open and Accepting

Florida

Mayo Clinic (Jacksonville)

Jacksonville, FL

Open and Accepting

Sylvester Comprehensive Cancer Center (Main) University of Miami Health System

Miami, FL

Not Yet Accepting

Moffitt Cancer Center Magnolia Campus

Tampa, FL

Open and Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting

Illinois

University of Chicago Medicine Comprehensive Cancer Center

Chicago, IL

Not Yet Accepting

Iowa

Holden Comprehensive Cancer Center - University of Iowa University of Iowa Hospitals and Clinics

Iowa City, IA

Open and Accepting

Massachusetts

Massachusetts General Hospital

Boston, MA

Open and Accepting

Michigan

University of Michigan Comprehensive Cancer Center Rogel Cancer Center

Ann Arbor, MI

Open and Accepting

Henry Ford Hospital

Detroit, MI

Open and Accepting

Minnesota

University of Minnesota - Masonic Cancer Center

Minneapolis, MN

Not Yet Accepting

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

Stony Brook University Hospital

Stony Brook, NY

Open and Accepting

North Carolina

Durham Veterans Affairs Medical Center

Durham, NC

Open and Accepting

Tennessee

Vanderbilt-Ingram Cancer Center Henry-Joyce Cancer Clinic

Nashville, TN

Open and Accepting

Sarah Cannon Research Institute TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Texas

South Austin Cancer Center

Austin, TX

Open and Accepting

St. David's South Austin Medical Center

Austin, TX

Open and Accepting

The University of Texas Southwestern Medical Center Harold C. Simmons Comprehensive Cancer Center

Dallas, TX

Open and Accepting

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Not Yet Accepting

Virginia

UVA Cancer Center University of Virginia Health System

Charlottesville, VA

Open and Accepting

Washington

Swedish Cancer Institute Swedish Edmonds Campus

Edmonds, WA

Not Yet Accepting

Fred Hutchinson Cancer Research Center University of Washington Cancer Consortium / SCCA

Seattle, WA

Not Yet Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Open and Accepting
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