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

Last updated: May 4, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1/2

Condition

Multiple Myeloma

Lymphoproliferative Disorders

Bone Neoplasm

Treatment

GC012F

GC012F (AZD0120)

AZD0120

Clinical Study ID

NCT05850234
D8310C00001
GC012F-CD19/BCMA-001
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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.

Study Design

Total Participants: 182
Treatment Group(s): 3
Primary Treatment: GC012F
Phase: 1/2
Study Start date:
July 20, 2023
Estimated Completion Date:
November 14, 2028

Study Description

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.

Connect with a study center

  • Research Site

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • UAB University of Alabama

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Mayo Clinic

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Research Site

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Research Site

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Research Site

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Research Site

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Research Site

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Colorado Blood and Cancer Institute

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Research Site

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Research Site

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Research Site

    Miami, Florida 33136
    United States

    Site Not Available

  • Research Site

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Research Site

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Research Site

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Research Site

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Research Site

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Research Site

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Research Site

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Research Site

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55901
    United States

    Active - Recruiting

  • Research Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Research Site

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Research Site

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Research Site

    Buffalo, New York 14203
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Research Site

    New York, New York 10065
    United States

    Active - Recruiting

  • Research Site

    Stony Brook, New York 11794
    United States

    Active - Recruiting

  • Research Site

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Research Site

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Research Site

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • SCRI Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Research Site

    Austin, Texas 78704
    United States

    Active - Recruiting

  • SAMC South Austin Medical Center

    Austin, Texas 78745
    United States

    Active - Recruiting

  • Research Site

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Research Site

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Research Site

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Research Site

    Edmonds, Washington 98026
    United States

    Active - Recruiting

  • Research Site

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • MCW Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • Research Site

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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