Multiple Myeloma Support + Trials

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:

* Males and females ≥18 years of age at the time of consent
* Written informed consent in accordance with federal, local, and institutional guidelines
* Have an ECOG performance status of 0 or 1
* Documented diagnosis of MM per IMWG diagnostic criteria
* Received at least three prior MM treatment lines of therapy
* Have received as part of their previous therapy a PI and IMiD and an antiCD38 antibody.
* Have documented evidence of progressive disease by the IMWG criteria.
* Subjects must have measurable disease at screening, as defined by any of the following: serum monoclonal paraprotein (M-protein) ≥1.0g/dL (10 g/L); urine M-protein ≥200 mg/24 h; serum FLC assay: involved FLC level is ≥10 mg/dL (100 mg/L) and serum kappa lambda FLC ratio is abnormal.
* Adequate bone marrow and organ function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP

Exclusion Criteria:

* Diagnosed or treated for invasive malignancy other than multiple myeloma, except: Malignancy treated with curative intent and with no known active disease present for ≥2 years before enrollment; or:
* Adequately treated non-melanoma skin cancer without evidence of disease.
* The following cardiac conditions:

* New York Heart Association (NYHA) stage III or IV congestive heart failure
* Myocardial infarction or coronary artery bypass graft (CABG) ≤6 months prior to enrollment
* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
* History of severe non-ischemic cardiomyopathy
* Received either of the following:

* An allogenic stem cell transplant within 6 months before apheresis. Subjects who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD).
* An autologous stem cell transplant ≤12 weeks before apheresis
* Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
* Plasma cell leukemia at the time of screening (\>2.0×109 /L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL amyloidosis.

Additional Trial Information

Phase 1/2

Enrollment: 80 patients (estimated)

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Interested in joining or learning more about this trial?

(888) 828-2206

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.

Trial Links

Read the latest news and updates on this trial.

AstraZeneca to add CAR T-cell therapy to pipeline with Gracell buy

January 02, 2024

All Trial Locations

View all clinical trial locations sorted by state.

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

Not Yet 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

Not Yet Accepting

Colorado

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

Not Yet Accepting

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

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

Interested in this trial?

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(888) 828-2206

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What's the purpose of this trial?

What will happen during the trial?

You may be able to join this trial if you:

Additional Trial Information

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

Trial Links

Trial Locations

All Trial Locations

Alabama

Open and Accepting

Arizona

Open and Accepting

California

Not Yet Accepting

Open and Accepting

Open and Accepting

Not Yet Accepting

Colorado

Open and Accepting

Florida

Not Yet Accepting

Not Yet Accepting

Open and Accepting

Georgia

Open and Accepting

Illinois

Not Yet Accepting

Iowa

Open and Accepting

Massachusetts

Not Yet Accepting

Michigan

Not Yet Accepting

Not Yet Accepting

Minnesota

Not Yet Accepting

Open and Accepting

New York

Open and Accepting

Open and Accepting

Open and Accepting

North Carolina

Not Yet Accepting

Tennessee

Open and Accepting

Not Yet Accepting

Texas

Open and Accepting

Open and Accepting

Open and Accepting

Open and Accepting

Utah

Not Yet Accepting

Virginia

Open and Accepting

Washington

Not Yet Accepting

Not Yet Accepting

Wisconsin

Open and Accepting