Actively Recruiting
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.
Led by AstraZeneca · Updated on 2026-04-30
508
Participants Needed
111
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AZD0120, a dual-targeted CAR-T cell therapy against BCMA and CD19, compared with four standard treatment regimens for adults with relapsed refractory multiple myeloma (RRMM). This Phase III randomized, open-label, multicenter global study aims to assess the efficacy and safety of AZD0120 in participants who have already received prior therapies. The study addresses the need for improved treatment options for RRMM patients who have experienced disease progression after previous treatments. Participants are randomly assigned to receive either AZD0120 or one of four standard regimens: DKd (daratumumab, carfilzomib, dexamethasone), DPd (daratumumab, pomalidomide, dexamethasone), PVd (pomalidomide, bortezomib, dexamethasone), or Kd (carfilzomib, dexamethasone). The choice of standard regimen is made by the investigator. AZD0120 is given as a biological CAR-T cell therapy. The study includes follow-up periods to assess treatment effects over several years. During the study, participants undergo regular assessments, including measurement of progression-free survival and minimal residual disease negativity rates. Additional measures include complete response rates, overall response rates, and overall survival. Safety and adverse effects are monitored throughout. The total duration of outcome measurement ranges from 2 to 5 years depending on the specific endpoint. Participants' health status, laboratory values, and disease progression are closely tracked to evaluate treatment impact and safety.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of multiple myeloma according to IMWG criteria
- Measurable disease with serum M-protein 1 g/dL, or urine M-protein 200 mg/24h, or serum free light chain 10 mg/dL with abnormal ratio
- Evidence of disease progression by IMWG 2016 criteria during or after most recent therapy
- Received 1 to 3 prior therapy lines including an IMiD and either a PI or CD38 antibody, with at least 2 complete cycles per line unless progression was best response
- Eligible for at least one standard regimen (DKd, PVd, DPd, or Kd) as per investigator
- ECOG performance status score of 0 to 1
- Adequate blood and chemistry lab values including hemoglobin 8.0 g/dL, neutrophils 1 x 10^9/L, platelet count 75 or 50 x 10^9/L depending on plasma cell marrow involvement, lymphocytes 300/bcl, bilirubin 1.5 x ULN (or 3 x ULN with Gilbert's), AST and ALT 3 x ULN, creatinine clearance 30 mL/min
You will not qualify if you...
- Active or prior CNS involvement or meningeal signs of multiple myeloma
- Primary amyloidosis, active plasma cell leukemia, Waldenstrom macroglobulinemia, or POEMS syndrome
- Primary refractory multiple myeloma with no minimal response to prior therapy
- Significant neurological or psychiatric conditions
- Medical conditions posing unacceptable treatment risk
- Prior BCMA-targeted therapy
- Prior CAR-T or CAR-NK therapy
- Prior T-cell engager therapy
- Prior allogeneic stem cell transplant or autologous transplant within 12 weeks before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years depending on treatment response and protocol
Participants receive either AZD0120, a dual-targeting CAR-T therapy, or one of the standard regimens (DKd, DPd, PVd, or Kd) per investigator choice to treat relapsed refractory multiple myeloma.
Regular visits as per treatment schedule
Duration - Up to 5 years
Participants are monitored for long-term outcomes including progression-free survival, minimal residual disease, and overall survival after completing treatment.
Periodic follow-up visits
Trial Site Locations
Total: 111 locations
1
Research Site
Gilbert, Arizona, United States, 85234
Not Yet Recruiting
2
Research Site
Phoenix, Arizona, United States, 85054
Not Yet Recruiting
3
Research Site
Tucson, Arizona, United States, 85719
Not Yet Recruiting
4
Research Site
La Jolla, California, United States, 92093
Withdrawn
5
Research Site
Sacramento, California, United States, 95817
Not Yet Recruiting
6
Research Site
Santa Monica, California, United States, 90404
Not Yet Recruiting
7
Research Site
Denver, Colorado, United States, 80218
Not Yet Recruiting
8
Research Site
New Haven, Connecticut, United States, 06510
Not Yet Recruiting
9
Research Site
Washington D.C., District of Columbia, United States, 20007
Not Yet Recruiting
10
Research Site
Coral Gables, Florida, United States, 33156
Not Yet Recruiting
11
Research Site
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
12
Research Site
Chicago, Illinois, United States, 60612
Not Yet Recruiting
13
Research Site
Park Ridge, Illinois, United States, 60068
Withdrawn
14
Research Site
Iowa City, Iowa, United States, 52242
Withdrawn
15
Research Site
Kansas City, Kansas, United States, 66160
Not Yet Recruiting
16
Research Site
Louisville, Kentucky, United States, 40207
Not Yet Recruiting
17
Research Site
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
18
Research Site
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
19
Research Site
Boston, Massachusetts, United States, 02215
Withdrawn
20
Research Site
Detroit, Michigan, United States, 48201
Withdrawn
21
Research Site
Detroit, Michigan, United States, 48202
Withdrawn
22
Research Site
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
23
Research Site
New York, New York, United States, 10016
Withdrawn
24
Research Site
New York, New York, United States, 10029
Not Yet Recruiting
25
Research Site
New York, New York, United States, 10065
Not Yet Recruiting
26
Research Site
Rochester, New York, United States, 14642
Withdrawn
27
Research Site
The Bronx, New York, United States, 10467
Withdrawn
28
Research Site
Chapel Hill, North Carolina, United States, 27514
Not Yet Recruiting
29
Research Site
Charlotte, North Carolina, United States, 28204
Not Yet Recruiting
30
Research Site
Winston-Salem, North Carolina, United States, 27103
Not Yet Recruiting
31
Research Site
Cincinnati, Ohio, United States, 45220
Not Yet Recruiting
32
Research Site
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
33
Research Site
Portland, Oregon, United States, 97239
Not Yet Recruiting
34
Research Site
Charleston, South Carolina, United States, 29425
Withdrawn
35
Research Site
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
36
Research Site
Austin, Texas, United States, 78704
Not Yet Recruiting
37
Research Site
Dallas, Texas, United States, 75235
Not Yet Recruiting
38
Research Site
Houston, Texas, United States, 77030
Not Yet Recruiting
39
Research Site
Salt Lake City, Utah, United States, 84112
Not Yet Recruiting
40
Research Site
Charlottesville, Virginia, United States, 22908
Withdrawn
41
Research Site
Richmond, Virginia, United States, 23298
Withdrawn
42
Research Site
Seattle, Washington, United States, 98104
Not Yet Recruiting
43
Research Site
Madison, Wisconsin, United States, 53792
Not Yet Recruiting
44
Research Site
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
45
Research Site
Camperdown, Australia, 2050
Not Yet Recruiting
46
Research Site
Darlinghurst, Australia, 2010
Not Yet Recruiting
47
Research Site
Fitzroy, Australia, VIC3065
Actively Recruiting
48
Research Site
Liverpool, Australia, 2170
Not Yet Recruiting
49
Research Site
Melbourne, Australia, 3000
Not Yet Recruiting
50
Research Site
Melbourne, Australia, 3004
Not Yet Recruiting
51
Research Site
Murdoch, Australia, WA6150
Not Yet Recruiting
52
Research Site
Salvador, Brazil, 41253-190
Not Yet Recruiting
53
Research Site
São Paulo, Brazil, 01509-900
Not Yet Recruiting
54
Research Site
São Paulo, Brazil, 05652-900
Not Yet Recruiting
55
Research Site
Calgary, Alberta, Canada, T2N 5G2
Not Yet Recruiting
56
Research Site
Vancouver, British Columbia, Canada, V5Z 4E6
Not Yet Recruiting
57
Research Site
Toronto, Ontario, Canada, M5G 2M9
Not Yet Recruiting
58
Research Site
Montreal, Quebec, Canada, H3A 1A1
Not Yet Recruiting
59
Research Site
Lille, France, 59037
Not Yet Recruiting
60
Research Site
Nantes, France, 44093
Not Yet Recruiting
61
Research Site
Paris, France, 75010
Not Yet Recruiting
62
Research Site
Pierre-Bénite, France, 69495
Not Yet Recruiting
63
Research Site
Poitiers, France, 86021
Not Yet Recruiting
64
Research Site
Toulouse, France, 31059
Not Yet Recruiting
65
Research Site
Berlin, Germany, 12200
Not Yet Recruiting
66
Research Site
Dresden, Germany, 01307
Not Yet Recruiting
67
Research Site
Erlangen, Germany, 91054
Not Yet Recruiting
68
Research Site
Essen, Germany, 45147
Not Yet Recruiting
69
Research Site
Freiburg im Breisgau, Germany, 79106
Not Yet Recruiting
70
Research Site
Hamburg, Germany, 20246
Not Yet Recruiting
71
Research Site
Leipzig, Germany, 04103
Not Yet Recruiting
72
Research Site
Mainz, Germany, 55131
Not Yet Recruiting
73
Research Site
Nuremberg, Germany, 90419
Not Yet Recruiting
74
Research Site
Würzburg, Germany, 97080
Not Yet Recruiting
75
Research Site
Bologna, Italy, 40138
Not Yet Recruiting
76
Research Site
Milan, Italy, 20132
Not Yet Recruiting
77
Research Site
Milan, Italy, 20133
Not Yet Recruiting
78
Research Site
Naples, Italy, 80131
Not Yet Recruiting
79
Research Site
Rozzano, Italy, 20089
Not Yet Recruiting
80
Research Site
Torino, Italy, 10126
Not Yet Recruiting
81
Research Site
Bunkyō City, Japan, 113-8431
Not Yet Recruiting
82
Research Site
Kashiwa, Japan, 277-8577
Not Yet Recruiting
83
Research Site
Kyoto, Japan, 602-8566
Not Yet Recruiting
84
Research Site
Nagoya, Japan, 467-8602
Not Yet Recruiting
85
Research Site
Shibuya-ku, Japan, 150-8935
Not Yet Recruiting
86
Research Site
Shinjuku-ku, Japan, 160-8582
Not Yet Recruiting
87
Research Site
Oslo, Norway, 0450
Not Yet Recruiting
88
Research Site
Gdansk, Poland, 80-952
Not Yet Recruiting
89
Research Site
Gliwice, Poland, 44-101
Not Yet Recruiting
90
Research Site
Lublin, Poland, 20-090
Not Yet Recruiting
91
Research Site
Poznan, Poland, 60-569
Not Yet Recruiting
92
Research Site
Warsaw, Poland, 02-776
Not Yet Recruiting
93
Research Site
Wroclaw, Poland, 50-367
Not Yet Recruiting
94
Research Site
Seoul, South Korea, 03080
Not Yet Recruiting
95
Research Site
Seoul, South Korea, 06351
Not Yet Recruiting
96
Research Site
Seoul, South Korea, 06591
Not Yet Recruiting
97
Research Site
Seoul, South Korea, 5505
Not Yet Recruiting
98
Research Site
Barcelona, Spain, 08036
Not Yet Recruiting
99
Research Site
Barcelona, Spain, 8035
Not Yet Recruiting
100
Research Site
Madrid, Spain, 28041
Not Yet Recruiting
101
Research Site
Pamplona, Spain, 31008
Not Yet Recruiting
102
Research Site
Salamanca, Spain, 37007
Not Yet Recruiting
103
Research Site
Santander, Spain, 39008
Not Yet Recruiting
104
Research Site
Valencia, Spain, 46026
Not Yet Recruiting
105
Research Site
Taipei, Taiwan, 10002
Not Yet Recruiting
106
Research Site
Taipei, Taiwan, 106
Not Yet Recruiting
107
Research Site
Taipei, Taiwan, 112
Not Yet Recruiting
108
Research Site
Birmingham, United Kingdom, B9 5SS
Not Yet Recruiting
109
Research Site
Bristol, United Kingdom, BS2 8ED
Not Yet Recruiting
110
Research Site
Glasgow, Scotland, United Kingdom, G12 0YN
Not Yet Recruiting
111
Research Site
London, United Kingdom, SM2 5NG
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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