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)

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by AstraZeneca
Sponsor
AstraZeneca
Information Provided by (Responsible Party)
AstraZeneca
Clinicaltrials.gov Identifier
NCT07391657
Other Study ID Numbers:
D8311C00001
First Submitted
January 29, 2026
First Posted
February 5, 2026
Last Update Posted
April 29, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Relapsed Refractory Multiple Myeloma
Biological: AZD0120Drug: Daratumumab

Study Design

Study TypeInterventional
Actual Enrollment508 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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.
Study Start DateFebruary 22, 2026
Actual Primary Completion Date2yrs 4w from now
Actual Study Completion Date4yrs 2mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Arm A
AZD0120
Biological: AZD0120
CAR-T Cells
Arm B
1 of the following 4 standard regimens per investigator choice; DKd, DPd, PVd, Kd.
Drug: Daratumumab
Daratumumab

Outcome Measures

Primary Outcome Measures
  1. 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.
  2. 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.
Secondary Outcome Measures
  1. 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. To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of ORR in participants with RRMM.
  3. To further demonstrate the effectiveness of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of OS in participants with RRMM.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsAstraZeneca
Locations
Research Site | Gilbert Arizona, United States, 85234Research Site | Phoenix Arizona, United States, 85054Research Site | Tucson Arizona, United States, 85719Research Site | La Jolla California, United States, 92093Research Site | Sacramento California, United States, 95817Research Site | Santa Monica California, United States, 90404Research Site | Denver Colorado, United States, 80218Research Site | New Haven Connecticut, United States, 06510Research Site | Washington D.C. District of Columbia, United States, 20007Research Site | Coral Gables Florida, United States, 33156Research Site | Atlanta Georgia, United States, 30322Research Site | Chicago Illinois, United States, 60612Research Site | Park Ridge Illinois, United States, 60068Research Site | Iowa City Iowa, United States, 52242Research Site | Kansas City Kansas, United States, 66160Research Site | Louisville Kentucky, United States, 40207Research Site | Boston Massachusetts, United States, 02114Research Site | Boston Massachusetts, United States, 02215Research Site | Boston Massachusetts, United States, 02215Research Site | Detroit Michigan, United States, 48201Research Site | Detroit Michigan, United States, 48202Research Site | Rochester Minnesota, United States, 55905Research Site | New York New York, United States, 10016Research Site | New York New York, United States, 10029Research Site | New York New York, United States, 10065Research Site | Rochester New York, United States, 14642Research Site | The Bronx New York, United States, 10467Research Site | Chapel Hill North Carolina, United States, 27514Research Site | Charlotte North Carolina, United States, 28204Research Site | Winston-Salem North Carolina, United States, 27103Research Site | Cincinnati Ohio, United States, 45220Research Site | Cleveland Ohio, United States, 44195Research Site | Portland Oregon, United States, 97239Research Site | Charleston South Carolina, United States, 29425Research Site | Nashville Tennessee, United States, 37203Research Site | Austin Texas, United States, 78704Research Site | Dallas Texas, United States, 75235Research Site | Houston Texas, United States, 77030Research Site | Salt Lake City Utah, United States, 84112Research Site | Charlottesville Virginia, United States, 22908Research Site | Richmond Virginia, United States, 23298Research Site | Seattle Washington, United States, 98104Research Site | Madison Wisconsin, United States, 53792Research Site | Milwaukee Wisconsin, United States, 53226Research Site | Camperdown , Australia, 2050Research Site | Darlinghurst , Australia, 2010Research Site | Fitzroy , Australia, VIC3065Research Site | Liverpool , Australia, 2170Research Site | Melbourne , Australia, 3000Research Site | Melbourne , Australia, 3004Research Site | Murdoch , Australia, WA6150Research Site | Salvador , Brazil, 41253-190Research Site | São Paulo , Brazil, 01509-900Research Site | São Paulo , Brazil, 05652-900Research Site | Calgary Alberta, Canada, T2N 5G2Research Site | Vancouver British Columbia, Canada, V5Z 4E6Research Site | Toronto Ontario, Canada, M5G 2M9Research Site | Montreal Quebec, Canada, H3A 1A1Research Site | Lille , France, 59037Research Site | Nantes , France, 44093Research Site | Paris , France, 75010Research Site | Pierre-Bénite , France, 69495Research Site | Poitiers , France, 86021Research Site | Toulouse , France, 31059Research Site | Berlin , Germany, 12200Research Site | Dresden , Germany, 01307Research Site | Erlangen , Germany, 91054Research Site | Essen , Germany, 45147Research Site | Freiburg im Breisgau , Germany, 79106Research Site | Hamburg , Germany, 20246Research Site | Leipzig , Germany, 04103Research Site | Mainz , Germany, 55131Research Site | Nuremberg , Germany, 90419Research Site | Würzburg , Germany, 97080Research Site | Bologna , Italy, 40138Research Site | Milan , Italy, 20132Research Site | Milan , Italy, 20133Research Site | Naples , Italy, 80131Research Site | Rozzano , Italy, 20089Research Site | Torino , Italy, 10126Research Site | Bunkyō City , Japan, 113-8431Research Site | Kashiwa , Japan, 277-8577Research Site | Kyoto , Japan, 602-8566Research Site | Nagoya , Japan, 467-8602Research Site | Shibuya-ku , Japan, 150-8935Research Site | Shinjuku-ku , Japan, 160-8582Research Site | Oslo , Norway, 0450Research Site | Gdansk , Poland, 80-952Research Site | Gliwice , Poland, 44-101Research Site | Lublin , Poland, 20-090Research Site | Poznan , Poland, 60-569Research Site | Warsaw , Poland, 02-776Research Site | Wroclaw , Poland, 50-367Research Site | Seoul , South Korea, 03080Research Site | Seoul , South Korea, 06351Research Site | Seoul , South Korea, 06591Research Site | Seoul , South Korea, 5505Research Site | Barcelona , Spain, 08036Research Site | Barcelona , Spain, 8035Research Site | Madrid , Spain, 28041Research Site | Pamplona , Spain, 31008Research Site | Salamanca , Spain, 37007Research Site | Santander , Spain, 39008Research Site | Valencia , Spain, 46026Research Site | Taipei , Taiwan, 10002Research Site | Taipei , Taiwan, 106Research Site | Taipei , Taiwan, 112Research Site | Birmingham , United Kingdom, B9 5SSResearch Site | Bristol , United Kingdom, BS2 8EDResearch Site | Glasgow, Scotland , United Kingdom, G12 0YNResearch Site | London , United Kingdom, SM2 5NG