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) (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.

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 Overview

• Status: Recruiting
• Conditions: Relapsed Refractory Multiple Myeloma
• Intervention / Treatment: Drug: Dexamethasone; Drug: Bortezomib; Drug: Carfilzomib; Drug: Daratumumab; Biological: AZD0120; Drug: Pomalidomide

• Study Type: Interventional
• Enrollment (Estimated): 508
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Australia
  • Camperdown, Australia, 2050
    • Not yet recruiting
    • Research Site
  • Darlinghurst, Australia, 2010
    • Not yet recruiting
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  • Fitzroy, Australia, VIC3065
    • Recruiting
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  • Liverpool, Australia, 2170
    • Not yet recruiting
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  • Melbourne, Australia, 3000
    • Not yet recruiting
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  • Melbourne, Australia, 3004
    • Not yet recruiting
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  • Murdoch, Australia, WA6150
    • Not yet recruiting
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• Brazil
  • Salvador, Brazil, 41253-190
    • Not yet recruiting
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  • São Paulo, Brazil, 05652-900
    • Not yet recruiting
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  • São Paulo, Brazil, 01509-900
    • Not yet recruiting
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• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 5G2
      • Not yet recruiting
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  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Not yet recruiting
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  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Not yet recruiting
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  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • Not yet recruiting
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• France
  • Lille, France, 59037
    • Not yet recruiting
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  • Nantes, France, 44093
    • Not yet recruiting
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  • Paris, France, 75010
    • Not yet recruiting
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  • Pierre-Bénite, France, 69495
    • Not yet recruiting
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  • Poitiers, France, 86021
    • Not yet recruiting
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  • Toulouse, France, 31059
    • Not yet recruiting
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• Germany
  • Berlin, Germany, 12200
    • Not yet recruiting
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  • Dresden, Germany, 01307
    • Not yet recruiting
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  • Erlangen, Germany, 91054
    • Not yet recruiting
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  • Essen, Germany, 45147
    • Not yet recruiting
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  • Freiburg im Breisgau, Germany, 79106
    • Not yet recruiting
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  • Hamburg, Germany, 20246
    • Not yet recruiting
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  • Leipzig, Germany, 04103
    • Not yet recruiting
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  • Mainz, Germany, 55131
    • Not yet recruiting
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  • Nuremberg, Germany, 90419
    • Not yet recruiting
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  • Würzburg, Germany, 97080
    • Not yet recruiting
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• Italy
  • Bologna, Italy, 40138
    • Not yet recruiting
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  • Milan, Italy, 20133
    • Not yet recruiting
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  • Milan, Italy, 20132
    • Not yet recruiting
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  • Naples, Italy, 80131
    • Not yet recruiting
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  • Rozzano, Italy, 20089
    • Not yet recruiting
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  • Torino, Italy, 10126
    • Not yet recruiting
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• Japan
  • Bunkyō City, Japan, 113-8431
    • Not yet recruiting
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  • Kashiwa, Japan, 277-8577
    • Not yet recruiting
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  • Kyoto, Japan, 602-8566
    • Not yet recruiting
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  • Nagoya, Japan, 467-8602
    • Not yet recruiting
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  • Shibuya-ku, Japan, 150-8935
    • Not yet recruiting
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  • Shinjuku-ku, Japan, 160-8582
    • Not yet recruiting
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• Norway
  • Oslo, Norway, 0450
    • Not yet recruiting
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• Poland
  • Gdansk, Poland, 80-952
    • Not yet recruiting
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  • Gliwice, Poland, 44-101
    • Not yet recruiting
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  • Lublin, Poland, 20-090
    • Not yet recruiting
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  • Poznan, Poland, 60-569
    • Not yet recruiting
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  • Warsaw, Poland, 02-776
    • Not yet recruiting
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  • Wroclaw, Poland, 50-367
    • Not yet recruiting
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• South Korea
  • Seoul, South Korea, 03080
    • Not yet recruiting
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  • Seoul, South Korea, 06591
    • Not yet recruiting
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  • Seoul, South Korea, 5505
    • Not yet recruiting
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  • Seoul, South Korea, 06351
    • Not yet recruiting
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• Spain
  • Barcelona, Spain, 08036
    • Not yet recruiting
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  • Barcelona, Spain, 8035
    • Not yet recruiting
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  • Madrid, Spain, 28041
    • Not yet recruiting
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  • Pamplona, Spain, 31008
    • Not yet recruiting
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  • Salamanca, Spain, 37007
    • Not yet recruiting
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  • Santander, Spain, 39008
    • Not yet recruiting
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  • Valencia, Spain, 46026
    • Not yet recruiting
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• Taiwan
  • Taipei, Taiwan, 10002
    • Not yet recruiting
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  • Taipei, Taiwan, 112
    • Not yet recruiting
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  • Taipei, Taiwan, 106
    • Not yet recruiting
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• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Not yet recruiting
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  • Bristol, United Kingdom, BS2 8ED
    • Not yet recruiting
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  • Glasgow, Scotland, United Kingdom, G12 0YN
    • Not yet recruiting
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  • London, United Kingdom, SM2 5NG
    • Not yet recruiting
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• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Not yet recruiting
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    • Phoenix, Arizona, United States, 85054
      • Not yet recruiting
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    • Tucson, Arizona, United States, 85719
      • Not yet recruiting
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  • California
    • La Jolla, California, United States, 92093
      • Withdrawn
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    • Sacramento, California, United States, 95817
      • Not yet recruiting
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    • Santa Monica, California, United States, 90404
      • Not yet recruiting
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  • Colorado
    • Denver, Colorado, United States, 80218
      • Not yet recruiting
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  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Not yet recruiting
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  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Not yet recruiting
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  • Florida
    • Coral Gables, Florida, United States, 33156
      • Not yet recruiting
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  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Not yet recruiting
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  • Illinois
    • Chicago, Illinois, United States, 60612
      • Not yet recruiting
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    • Park Ridge, Illinois, United States, 60068
      • Withdrawn
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  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Withdrawn
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  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Not yet recruiting
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  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Not yet recruiting
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  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Withdrawn
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    • Boston, Massachusetts, United States, 02114
      • Not yet recruiting
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    • Boston, Massachusetts, United States, 02215
      • Not yet recruiting
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  • Michigan
    • Detroit, Michigan, United States, 48201
      • Withdrawn
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    • Detroit, Michigan, United States, 48202
      • Withdrawn
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  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Not yet recruiting
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  • New York
    • New York, New York, United States, 10029
      • Not yet recruiting
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    • New York, New York, United States, 10065
      • Not yet recruiting
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    • New York, New York, United States, 10016
      • Withdrawn
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    • Rochester, New York, United States, 14642
      • Withdrawn
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    • The Bronx, New York, United States, 10467
      • Withdrawn
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  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Not yet recruiting
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    • Charlotte, North Carolina, United States, 28204
      • Not yet recruiting
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    • Winston-Salem, North Carolina, United States, 27103
      • Not yet recruiting
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  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Not yet recruiting
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    • Cleveland, Ohio, United States, 44195
      • Not yet recruiting
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  • Oregon
    • Portland, Oregon, United States, 97239
      • Not yet recruiting
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  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Withdrawn
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  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Not yet recruiting
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  • Texas
    • Austin, Texas, United States, 78704
      • Not yet recruiting
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    • Dallas, Texas, United States, 75235
      • Not yet recruiting
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    • Houston, Texas, United States, 77030
      • Not yet recruiting
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  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Not yet recruiting
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  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Withdrawn
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    • Richmond, Virginia, United States, 23298
      • Withdrawn
      • Research Site
  • Washington
    • Seattle, Washington, United States, 98104
      • Not yet recruiting
      • Research Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Not yet recruiting
      • Research Site
    • Milwaukee, Wisconsin, United States, 53226
      • Not yet recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; AZD0120	Biological: AZD0120; CAR-T Cells
Active Comparator: Arm B; 1 of the following 4 standard regimens per investigator choice; DKd, DPd, PVd, Kd.	Drug: Dexamethasone; Dexamethasone; Drug: Bortezomib; Bortezomib; Other Names: Velcade; Drug: Carfilzomib; Carfilzomib; Other Names: Kyprolis; Drug: Daratumumab; Daratumumab; Other Names: Darzalex; Drug: Pomalidomide; Pomalidomides; Other Names: Pomalyst and Imnovid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of PFS in participants with RRMM.	PFS: defined as time from randomisation until progression according to IMWG 2016 criteria as assessed by BICR, or death due to any cause, whichever occurs first.	3 years
To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of MRD negativity rate at 9 months in participants with RRMM.	MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status and have a response of CR or sCR (according to the IMWG 2016 criteria) at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of CRR in participants with RRMM.	2 years
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of ORR in participants with RRMM.	2 years
To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of OS in participants with RRMM.	5 years

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2026
• Primary Completion (Estimated): June 14, 2028
• Study Completion (Estimated): August 12, 2030

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: CAR-T; CD19; BCMA
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Inorganic Chemicals; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Boronic Acids; Acids, Noncarboxylic; Acids; Boron Compounds; Pyrazines; Bortezomib; Dexamethasone; carfilzomib; pomalidomide; daratumumab
• Other Study ID Numbers: D8311C00001; AZD0120 (Other Identifier: AstraZeneca)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No