2025-523285-25-00
Recruiting
Phase 3
A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, versus Standard Regimens in Participants with Relapsed Refractory Multiple Myeloma (DURGA-4)
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- AstraZeneca AB
- Enrollment
- 38
Overview
Brief Summary
Arm A and Arm B Primary Objective 1: To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of PFS in participants with RRMM. Primary Objective 2: To demonstrate the superiority of AZD0120 relative to standard therapy (DKd, DPd, PVd, or Kd) by assessment of MRD negative CR rate at 9 months in participants with RRMM.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Arm A and B: Participants must be 18 years or older, at the time of signing the ICF.
- •Arm A and B: Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria.
- •Arm A and B: Participant must have one or more of the following measurable disease criteria: (a) Serum M-protein level ≥1.0 g/dL, (b) Urine M-protein level ≥ 200 mg/24 h, (c) Serum immunoglobulin FLC ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda FLC ratio.
- •Arm A and B: Participant must have documented evidence of PD by IMWG 2016 criteria based on Investigator’s determination during or after the most recent line of therapy. Participants who have had only 1 prior line of therapy must have disease that has progressed within 47 months of a stem cell transplant, or if not transplanted, then within 42 months of starting initial therapy.
- •Arm A and B: Participant must have received 1 to 3 lines of prior therapy including an IMiD and either a PI or an anti-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.
- •Arm A and B: Participant is eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator.
- •Arm A and B: Participants must have an ECOG performance status score of 0 to
- •Arm A and B: Adequate organ and bone marrow function.
Exclusion Criteria
- •Arm A and B: Participant has active or prior CNS or meningeal involvement of MM.
- •Arm A and B: Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome.
- •Arm A and B: Participant has primary refractory MM (no minimal response to any prior therapy).
- •Arm A and B: Participant has significant neurological or psychiatric condition posing risk or impairing evaluation (e.g., severe brain injury, dementia, Parkinson’s, stroke, intracranial hemorrhage, or seizure within 6 months). Stable mild conditions may be eligible at Investigator discretion.
- •Arm A and B: Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation, including: -Serious active or uncontrolled infection, -Requirement of supplemental oxygen, -Active autoimmune disease or history within 2 years, -Clinically significant gastrointestinal disease (including IBD requiring treatment within 5 years).
- •Arm A and B: Participant previously received any BCMA-targeted treatment.
- •Arm A and B: Participant previously received CAR-T or CAR-NK therapy.
- •Arm A and B: Participant previously received T-cell engager therapy.
- •Arm A and B: Participant previously received allogeneic stem cell transplant at any time or ASCT within 12 weeks before randomization.
Investigators
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
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