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

May 4, 2026 updated by: AstraZeneca

A Phase Ib/II Study of AZD0120, Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against CD19 and B-cell Maturation Antigen (BCMA) in Participants With Relapsed/Refractory Multiple Myeloma (DURGA-1)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

182

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Research Site
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Research Site
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Research Site
      • San Francisco, California, United States, 94143
        • Recruiting
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Research Site
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Research Site
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • Research Site
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Research Site
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • Research Site
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Not yet recruiting
        • Research Site
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Withdrawn
        • Research Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Withdrawn
        • Research Site
    • New York
      • Buffalo, New York, United States, 14203
        • Not yet recruiting
        • Research Site
      • New York, New York, United States, 10065
        • Recruiting
        • Research Site
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Research Site
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Research Site
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Research Site
    • Texas
      • Austin, Texas, United States, 78704
        • Recruiting
        • Research Site
      • Dallas, Texas, United States, 75390
        • Recruiting
        • Research Site
      • Houston, Texas, United States, 77030
        • Recruiting
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Not yet recruiting
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • Research Site
    • Washington
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Research Site
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZD0120
AZD0120 will be administered by infusion
Biological: AZD0120
AZD0120 is a BCMA/CD19 dual CAR T product under investigation for the treatment of participants with RRMM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1b: Adverse Events (AEs)
Time Frame: Through study completion, a minimum of 2 years.
The incidence and severity of AEs.
Through study completion, a minimum of 2 years.
Phase 1b: Dose-Limiting Toxicities (DLTs)
Time Frame: 28 days
The DLT evaluation period is defined as the first 28 days after infusion.
28 days
Phase 2: Objective Response Rate (ORR)
Time Frame: Through study completion, a minimum of 2 years.
Defined as the proportion of participants who achieved partial response (PR) or better by the International Myeloma Working Group (IMWG) response criteria.
Through study completion, a minimum of 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1b and 2: Complete response rate (CRR)
Time Frame: Through study completion, a minimum of 2 years.
Defined as the proportion of participants who achieved complete response (CR) or better per International Myeloma Working Group (IMWG) criteria.
Through study completion, a minimum of 2 years.
Phase 1b and 2: Time to response (TTR)
Time Frame: Through study completion, a minimum of 2 years.
Defined as the time between date of the initial infusion of AZD0120 and the first efficacy evaluation that the participant has met all criteria for partial response (PR) or better.
Through study completion, a minimum of 2 years.
Phase 1b: Objective Response Rate (ORR)
Time Frame: Through study completion, a minimum of 2 years.
Defined as the proportion of participants who achieved PR or better by IMWG response criteria.
Through study completion, a minimum of 2 years.
Phase 1b and 2: Minimal Residual Disease (MRD) negative Complete Response (CR) rate
Time Frame: Through study completion, a minimum of 2 years.
Defined as the proportion of participants who achieve CR or better response with MRD negativity per IMWG criteria.
Through study completion, a minimum of 2 years.
Phase 1b and 2: Duration of response (DOR)
Time Frame: Through study completion, a minimum of 2 years.
Defined among responders as the time from the date of initial documentation of an objective response (overall response of PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.
Through study completion, a minimum of 2 years.
Phase 1b and 2: Progression-free survival (PFS)
Time Frame: Through study completion, a minimum of 2 years.
Defined as the time from the date of the initial infusion of AZD0120 to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.
Through study completion, a minimum of 2 years.
Phase 1b and 2: Overall survival (OS)
Time Frame: Through study completion, a minimum of 2 years.
Defined as the time from the date of the initial infusion of AZD0120 to the date of the subject's death.
Through study completion, a minimum of 2 years.
Phase 2: Adverse Events (AEs)
Time Frame: Through study completion, a minimum of 2 years.
Further characterization of the safety of AZD0120 by measuring the incidence and severity of AEs.
Through study completion, a minimum of 2 years.
Ph1b and 2: Pharmacokinetics - AUC
Time Frame: Through study completion, a minimum of 2 years.
Area under the concentration time-curve of AZD0120 CAR transgene copies.
Through study completion, a minimum of 2 years.
Ph1b and 2: Pharmacokinetics - Clast
Time Frame: Through study completion, a minimum of 2 years.
Last quantifiable AZD0120 CAR transgene copies.
Through study completion, a minimum of 2 years.
Ph1b and 2: Pharmacokinetics - Cmax
Time Frame: Through study completion, a minimum of 2 years.
Maximum AZD0120 CAR transgene copies.
Through study completion, a minimum of 2 years.
Ph1b and 2: Pharmacokinetics - Tlast
Time Frame: Through study completion, a minimum of 2 years.
Time to last quantifiable AZD0120 CAR transgene copies.
Through study completion, a minimum of 2 years.
Ph1b and 2: Pharmacokinetics - Tmax
Time Frame: Through study completion, a minimum of 2 years
Time to reach maximum AZD0120 CAR transgene copies.
Through study completion, a minimum of 2 years
Ph1b and 2: Humoral Immunogenicity
Time Frame: Through study completion, a minimum of 2 years.
Serum samples will be analyzed for anti-drug antibodies (ADA) against AZD0120 using a validated immunoassay. Incidence and prevalence of treatment-emergent ADA will be summarized, with descriptive analyses of associations with pharmacokinetics, efficacy, and safety.
Through study completion, a minimum of 2 years.
Phase 2: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire IL355 (EORTC IL355)
Time Frame: Through study completion, a minimum of 2 years.
Changes from baseline in EORTC IL355 to assess the bone pain and other aspects of function.
Through study completion, a minimum of 2 years.
Phase 2: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire EORTC IL356
Time Frame: Through study completion, a minimum of 2 years.
Changes from baseline in EORTC IL356 to assess the symptomatic toxicities and physical functioning.
Through study completion, a minimum of 2 years.
Phase 1b and 2: Minimal Residual Disease (MRD) negative Complete Response (CR) rate at 12 months
Time Frame: 12 months
Defined as the proportion of participants who achieve CR or better response with MRD negativity per IMWG criteria at 12 months.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Yingda Wen, Gracell Biopharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2023

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

November 14, 2028

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

April 28, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8310C00001
  • GC012F-CD19/BCMA-001 (Other Identifier: Gracell Biopharmaceuticals)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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