A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120 in Participants With Multiple Myeloma (DURGA-2)

Last updated: September 24, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1

Condition

Red Blood Cell Disorders

Lymphoproliferative Disorders

Multiple Myeloma

Treatment

AZD0120

GC012F (AZD0120)

Clinical Study ID

NCT07073547
D831EC00001
  • Ages > 18
  • All Genders

Study Summary

This is an interventional, modular, open-label, multicenter study to primarily evaluate the safety and tolerability of AZD0120 in adult participants with multiple myeloma (MM).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age:

  • Males and females ≥18 years of age at the time of consent

Type of Participant and Disease Characteristics:

  • Participant must have documented diagnosis of MM per IMWG diagnostic criteria

  • ECOG performance status of 0 or 1.

  • Adequate organ and bone marrow function.

For NDMM participants:

  • Participants on Module 1: Newly diagnosed multiple myeloma (NDMM) without prioranti- myeloma therapy (no more than 2 cycles of induction therapy before enrollmentare acceptable)

  • For participants on Module 2: Newly diagnosed MM with a minimum of 4 cycles and amaximum of 6 cycles of induction therapy completed prior to screening

  • Classified as high-risk MM

For Early Relapsed or Primary Refractory MM (1 or 2 prior lines of therapy) participants:

  • Have received and failed 1 or 2 lines of anti-myeloma therapy

  • Have received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) as partof their previous therapy

  • Have documented evidence of progressive disease based on investigator'sdetermination of response by the IMWG criteria within 1 year of starting treatment,or on or within 6 months of completing treatment of the subject's last line ofanti-myeloma therapy, or have confirmed progressive disease within 6 months prior toscreening and who are subsequently determined to be refractory or non-responsive totheir most recent anti-myeloma treatment regimen

Exclusion

General Exclusion Criteria:

  • Have received prior treatment with CAR T therapy directed at any target

  • Known active, or prior history of central nervous system (CNS) involvement orexhibits clinical signs of meningeal involvement of multiple myeloma

  • Active or history of plasma cell leukemia at the time of screening

  • Seropositive for human immunodeficiency virus (HIV)

  • Active Hepatitis B infection

  • Active Hepatitis C infection

  • Serious underlying medical condition

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: AZD0120
Phase: 1
Study Start date:
July 31, 2025
Estimated Completion Date:
May 26, 2028

Study Description

This modular study aims to evaluate the safety, tolerability, cellular kinetics, pharmacodynamic effect, immunogenicity, and preliminary efficacy of AZD0120 in subjects with newly diagnosed or early relapsed or primary refractory multiple myeloma. Module 1 consists of early line MM (including newly diagnosed MM and early relapsed or primary refractory MM) with AZD0120 (for newly diagnosed multiple myeloma (NDMM), the intervention is with AZD0120 ± maintenance). Module 2 consists of NDMM with AZD0120 ± maintenance.

Connect with a study center

  • Research Site

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Research Site

    Duarte, California 91010
    United States

    Active - Recruiting

  • Research Site

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Research Site

    Tampa, Florida 33612
    United States

    Site Not Available

  • Research Site

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Research Site

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Research Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Research Site

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • Research Site

    New York, New York 10016
    United States

    Active - Recruiting

  • Research Site

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Research Site

    Dallas, Texas 75235
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Research Site

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

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