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RECRUITING

NCT07391657

PHASE3

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

View on ClinicalTrials.gov

Summary

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

508

Start Date

2026-02-23

Completion Date

2030-07-29

Last Updated

2026-03-12

Healthy Volunteers

Conditions

Relapsed Refractory Multiple Myeloma

Interventions

BIOLOGICAL

AZD0120

CAR-T Cells

DRUG

Daratumumab

DRUG

Carfilzomib

DRUG

Dexamethasone

DRUG

Bortezomib

DRUG

Pomalidomide

Pomalidomides

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

Locations (108)

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Gilbert, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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La Jolla, California, United States

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Santa Monica, California, United States

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Denver, Colorado, United States

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New Haven, Connecticut, United States

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

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Park Ridge, Illinois, United States

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Iowa City, Iowa, United States

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Kansas City, Kansas, United States

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Louisville, Kentucky, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Rochester, Minnesota, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Portland, Oregon, United States

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Charleston, South Carolina, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Camperdown, Australia

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Darlinghurst, Australia

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Fitzroy, Australia

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Liverpool, Australia

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Melbourne, Australia

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Melbourne, Australia

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Murdoch, Australia

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Salvador, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Lille, France

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Nantes, France

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Paris, France

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Pierre-Bénite, France

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Poitiers, France

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Toulouse, France

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Berlin, Germany

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Dresden, Germany

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Erlangen, Germany

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Essen, Germany

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Freiburg im Breisgau, Germany

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Hamburg, Germany

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Leipzig, Germany

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Mainz, Germany

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Nuremberg, Germany

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Würzburg, Germany

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Bologna, Italy

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Milan, Italy

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Milan, Italy

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Naples, Italy

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Rozzano, Italy

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Torino, Italy

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Bunkyō City, Japan

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Kashiwa, Japan

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Kyoto, Japan

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Nagoya, Japan

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Shibuya-ku, Japan

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Shinjuku-ku, Japan

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Oslo, Norway

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Gdansk, Poland

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Gliwice, Poland

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Lublin, Poland

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Poznan, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Barcelona, Spain

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Barcelona, Spain

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Madrid, Spain

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Pamplona, Spain

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Salamanca, Spain

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Santander, Spain

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Valencia, Spain

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Taipei, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Birmingham, United Kingdom

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Bristol, United Kingdom

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Glasgow, Scotland, United Kingdom

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London, United Kingdom

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (108)