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NCT07391657From ClinicalTrials.govRecruiting

A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)

A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CART) Therapy Directed Against BCMA and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma.

  • Relapsed Refractory Multiple Myeloma

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
AstraZeneca
Enrolment target
508
Started
23 February 2026
Main results due
14 June 2028
Study sites
143
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* Age ≥ 18 years
* Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria
* Documented evidence of measurable disease:

  1. Serum M-protein level ≥ 1 g/dL
  2. Urine M-protein level ≥ 200 mg/24h
  3. Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
* Documented evidence of PD by IMWG 2016 criteria based on investigator's determination during or after the most recent line of therapy. Participants with only 1 prior line of therapy must have progressed within 47 months of a stem cell transplant, or if not transplanted, then within 42 months of starting initial therapy
* Received 1 to 3 lines of prior therapy including an IMiD and either a PI or a CD38 antibody. Participant must have undergone at least 2 complete cycles of treatment for each line of therapy, unless PD was the best response to the line of therapy
* Eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator.
* ECOG performance status score of 0 to 1
* Adequate hematology and chemistry laboratory values:

  1. Haemoglobin ≥ 8.0 g/dL
  2. Absolute neutrophil count ≥ 1 × 10\^9/L (1000 per mm3)
  3. Platelet count ≥ 75 × 10\^9/L (75000 per mm3) in participants with \< 50% of bone marrow nucleated cells are plasma cells or ≥ 50 × 10\^9/L (50000 per mm3) in participants with ≥ 50% of bone marrow nucleated cells are plasma cells
  4. Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L)
  5. Total bilirubin ≤ 1.5 × ULN in the absence of Gilbert's syndrome or ≤ 3 × ULN if the participant has Gilbert's syndrome. AST and ALT≤ 3.0 × ULN. CrCl by Cockcroft and Gault method ≥ 30 mL/minute

Exclusion Criteria:

* Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.
* Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome.
* Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy)
* Significant neurological or psychiatric condition
* Significant medical condition that places the participant at an unacceptable risk for treatment-related complications
* Previously received any prior BCMA-targeted treatment
* Previously received CAR-T or CAR-NK therapy directed at any target
* Previously received T-cell engager therapy directed at any target
* Previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of randomization

What this study is about

In the sponsor’s own words, from the registry.

This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (DKd \[daratumumab, carfilzomib, and dexamethasone\], DPd \[daratumumab, pomalidomide, and dexamethasone\], PVd \[pomalidomide, bortezomib and dexamethasone\], or Kd \[carfilzomib and dexamethasone\]) in participants with RRMM.

Study sites(143)

  • Research Site

    Gilbert, Arizona, United States

    Not yet recruiting

  • Research Site

    Phoenix, Arizona, United States

    Withdrawn

  • Research Site

    Tucson, Arizona, United States

    Not yet recruiting

  • Research Site

    La Jolla, California, United States

    Withdrawn

  • Research Site

    Sacramento, California, United States

    Not yet recruiting

  • Research Site

    Santa Monica, California, United States

    Not yet recruiting

  • Research Site

    Denver, Colorado, United States

    Recruiting

  • Research Site

    New Haven, Connecticut, United States

    Recruiting

  • Research Site

    Washington D.C., District of Columbia, United States

    Not yet recruiting

  • Research Site

    Coral Gables, Florida, United States

    Withdrawn

  • Research Site

    Tampa, Florida, United States

    Not yet recruiting

  • Research Site

    Atlanta, Georgia, United States

    Recruiting

  • Research Site

    Chicago, Illinois, United States

    Not yet recruiting

  • Research Site

    Park Ridge, Illinois, United States

    Not yet recruiting

  • Research Site

    Iowa City, Iowa, United States

    Withdrawn

  • Research Site

    Kansas City, Kansas, United States

    Not yet recruiting

  • Research Site

    Louisville, Kentucky, United States

    Recruiting

  • Research Site

    Boston, Massachusetts, United States

    Not yet recruiting

  • Research Site

    Boston, Massachusetts, United States

    Not yet recruiting

  • Research Site

    Boston, Massachusetts, United States

    Withdrawn

  • Research Site

    Detroit, Michigan, United States

    Withdrawn

  • Research Site

    Detroit, Michigan, United States

    Withdrawn

  • Research Site

    Rochester, Minnesota, United States

    Withdrawn

  • Research Site

    Albany, New York, United States

    Not yet recruiting

  • Research Site

    New York, New York, United States

    Withdrawn

  • Research Site

    New York, New York, United States

    Recruiting

  • Research Site

    New York, New York, United States

    Withdrawn

  • Research Site

    New York, New York, United States

    Recruiting

  • Research Site

    Rochester, New York, United States

    Withdrawn

  • Research Site

    The Bronx, New York, United States

    Withdrawn

  • Research Site

    Chapel Hill, North Carolina, United States

    Not yet recruiting

  • Research Site

    Charlotte, North Carolina, United States

    Not yet recruiting

  • Research Site

    Charlotte, North Carolina, United States

    Recruiting

  • Research Site

    Winston-Salem, North Carolina, United States

    Recruiting

  • Research Site

    Winston-Salem, North Carolina, United States

    Not yet recruiting

  • Research Site

    Cincinnati, Ohio, United States

    Not yet recruiting

  • Research Site

    Cleveland, Ohio, United States

    Not yet recruiting

  • Research Site

    Portland, Oregon, United States

    Not yet recruiting

  • Research Site

    Charleston, South Carolina, United States

    Withdrawn

  • Research Site

    Nashville, Tennessee, United States

    Recruiting

  • Research Site

    Austin, Texas, United States

    Recruiting

  • Research Site

    Dallas, Texas, United States

    Not yet recruiting

  • Research Site

    Houston, Texas, United States

    Recruiting

  • Research Site

    Salt Lake City, Utah, United States

    Not yet recruiting

  • Research Site

    Charlottesville, Virginia, United States

    Withdrawn

  • Research Site

    Gainesville, Virginia, United States

    Not yet recruiting

  • Research Site

    Richmond, Virginia, United States

    Withdrawn

  • Research Site

    Puyallup, Washington, United States

    Not yet recruiting

  • Research Site

    Seattle, Washington, United States

    Recruiting

  • Research Site

    Madison, Wisconsin, United States

    Not yet recruiting

  • Research Site

    Milwaukee, Wisconsin, United States

    Recruiting

  • Research Site

    Camperdown, Australia

    Recruiting

  • Research Site

    Darlinghurst, Australia

    Recruiting

  • Research Site

    Fitzroy, Australia

    Recruiting

  • Research Site

    Liverpool, Australia

    Not yet recruiting

  • Research Site

    Melbourne, Australia

    Recruiting

  • Research Site

    Melbourne, Australia

    Recruiting

  • Research Site

    Murdoch, Australia

    Not yet recruiting

  • Research Site

    Salvador, Brazil

    Recruiting

  • Research Site

    São Paulo, Brazil

    Recruiting

Showing 60 of 143 sites — filter to narrow it down. 40 of the 143 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07391657. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Sta | Trialion