RecruitingPhase 3NCT07391657

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.

Sponsor

AstraZeneca

Enrollment

508 participants

Start Date

Feb 23, 2026

Study Type

INTERVENTIONAL

Conditions

Relapsed/Refractory Multiple Myeloma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (DURGA-4) is testing a new CAR-T cell therapy called AZD0120 versus standard treatment for people with multiple myeloma — a blood cancer — that has come back or stopped responding to previous therapies. AZD0120 is an engineered immune cell therapy that targets two proteins on myeloma cells (BCMA and CD19) at the same time. **You may be eligible if...** - You are 18 or older - You have been diagnosed with multiple myeloma - Your myeloma has measurable disease (detectable in blood or urine tests) - You have received 1 to 3 prior lines of treatment, including an immunomodulatory drug (IMiD) and either a proteasome inhibitor or a CD38 antibody - Your cancer has progressed during or after your most recent treatment **You may NOT be eligible if...** - You have received more than 3 prior lines of therapy - You have previously received BCMA-targeted CAR-T therapy or bispecific antibodies - You have active or uncontrolled infections (including HIV or hepatitis) - You have serious heart or lung problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAZD0120

CAR-T Cells

DRUGDaratumumab

Daratumumab

DRUGCarfilzomib

Carfilzomib

DRUGDexamethasone

Dexamethasone

DRUGBortezomib

Bortezomib

DRUGPomalidomide

Pomalidomides

Locations(111)

Research Site

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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Sacramento, 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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Coral Gables, Florida, 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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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

Research Site

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

Research Site

Seoul, South Korea

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Seoul, South Korea

Research Site

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

Research Site

Valencia, Spain

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Taipei, Taiwan

Research Site

Taipei, Taiwan

Research Site

Taipei, Taiwan

Research Site

Birmingham, United Kingdom

Research Site

Bristol, United Kingdom

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Glasgow, Scotland, United Kingdom

Research Site

London, United Kingdom

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