RECRUITING Phase 3 ClinicalTrials.gov

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)

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT07391657

Registry updated: 2026-09-29

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Description

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.

Interventions

AZD0120 (Biological)
CAR-T Cells
Daratumumab (Drug)
Daratumumab
Carfilzomib (Drug)
Carfilzomib
Dexamethasone (Drug)
Dexamethasone
Bortezomib (Drug)
Bortezomib
Pomalidomide (Drug)
Pomalidomides

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

Conditions

Relapsed Refractory Multiple Myeloma

Locations

Research Site — Gilbert, Arizona, United States
Research Site — Phoenix, Arizona, United States
Research Site — Tucson, Arizona, United States
Research Site — La Jolla, California, United States
Research Site — Sacramento, California, United States
Research Site — Santa Monica, California, United States
Research Site — Denver, Colorado, United States
Research Site — New Haven, Connecticut, United States
Research Site — Washington D.C., District of Columbia, United States
Research Site — Coral Gables, Florida, United States
Research Site — Tampa, Florida, United States
Research Site — Atlanta, Georgia, United States
Research Site — Chicago, Illinois, United States
Research Site — Park Ridge, Illinois, United States
Research Site — Iowa City, Iowa, United States
Research Site — Kansas City, Kansas, United States
Research Site — Louisville, Kentucky, United States
Research Site — Boston, Massachusetts, United States
Research Site — Boston, Massachusetts, United States
Research Site — Boston, Massachusetts, United States
Research Site — Detroit, Michigan, United States
Research Site — Detroit, Michigan, United States
Research Site — Rochester, Minnesota, United States
Research Site — Albany, New York, United States
Research Site — New York, New York, United States
Research Site — New York, New York, United States
Research Site — New York, New York, United States
Research Site — New York, New York, United States
Research Site — Rochester, New York, United States
Research Site — The Bronx, New York, United States
Research Site — Chapel Hill, North Carolina, United States
Research Site — Charlotte, North Carolina, United States
Research Site — Charlotte, North Carolina, United States
Research Site — Winston-Salem, North Carolina, United States
Research Site — Winston-Salem, North Carolina, United States
Research Site — Cincinnati, Ohio, United States
Research Site — Cleveland, Ohio, United States
Research Site — Portland, Oregon, United States
Research Site — Charleston, South Carolina, United States
Research Site — Nashville, Tennessee, United States
Research Site — Austin, Texas, United States
Research Site — Dallas, Texas, United States
Research Site — Houston, Texas, United States
Research Site — Salt Lake City, Utah, United States
Research Site — Charlottesville, Virginia, United States
Research Site — Gainesville, Virginia, United States
Research Site — Richmond, Virginia, United States
Research Site — Puyallup, Washington, United States
Research Site — Seattle, Washington, United States
Research Site — Madison, Wisconsin, United States
Research Site — Milwaukee, Wisconsin, United States
Research Site — Camperdown, Australia
Research Site — Darlinghurst, Australia
Research Site — Fitzroy, Australia
Research Site — Liverpool, Australia
Research Site — Melbourne, Australia
Research Site — Melbourne, Australia
Research Site — Murdoch, Australia
Research Site — Salvador, Brazil
Research Site — São Paulo, Brazil
Research Site — São Paulo, Brazil
Research Site — Calgary, Alberta, Canada
Research Site — Vancouver, British Columbia, Canada
Research Site — Toronto, Ontario, Canada
Research Site — Montreal, Quebec, Canada
Research Site — Beijing, China
Research Site — Beijing, China
Research Site — Changchun, China
Research Site — Changsha, China
Research Site — Changsha, China
Research Site — Chongqing, China
Research Site — Guangzhou, China
Research Site — Guangzhou, China
Research Site — Hefei, China
Research Site — Nanchang, China
Research Site — Nanchang, China
Research Site — Nanjing, China
Research Site — Ningbo, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Shenzhen, China
Research Site — Tianjin, China
Research Site — Wenzhou, China
Research Site — Wuhan, China
Research Site — Xi'an, China
Research Site — Xi'an, China
Research Site — Zhengzhou, China
Research Site — Zhengzhou, China
Research Site — Lille, France
Research Site — Nantes, France
Research Site — Paris, France
Research Site — Pierre-Bénite, France
Research Site — Poitiers, France
Research Site — Toulouse, France
Research Site — Berlin, Germany
Research Site — Dresden, Germany
Research Site — Erlangen, Germany
Research Site — Essen, Germany
Research Site — Freiburg im Breisgau, Germany
Research Site — Hamburg, Germany
Research Site — Leipzig, Germany
Research Site — Mainz, Germany
Research Site — München, Germany
Research Site — Nuremberg, Germany
Research Site — Würzburg, Germany
Research Site — Bologna, Italy
Research Site — Milan, Italy
Research Site — Milan, Italy
Research Site — Naples, Italy
Research Site — Rozzano, Italy
Research Site — Torino, Italy
Research Site — Bunkyō City, Japan
Research Site — Kashiwa, Japan
Research Site — Kyoto, Japan
Research Site — Nagoya, Japan
Research Site — Shibuya-ku, Japan
Research Site — Shinjuku-ku, Japan
Research Site — Oslo, Norway
Research Site — Gdansk, Poland
Research Site — Gliwice, Poland
Research Site — Lublin, Poland
Research Site — Poznan, Poland
Research Site — Warsaw, Poland
Research Site — Wroclaw, Poland
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Barcelona, Spain
Research Site — Barcelona, Spain
Research Site — Madrid, Spain
Research Site — Pamplona, Spain
Research Site — Salamanca, Spain
Research Site — Santander, Spain
Research Site — Valencia, Spain
Research Site — Taipei, Taiwan
Research Site — Taipei, Taiwan
Research Site — Taipei, Taiwan
Research Site — Birmingham, United Kingdom
Research Site — Bristol, United Kingdom
Research Site — Glasgow, Scotland, United Kingdom
Research Site — London, United Kingdom

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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