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 vizsgálat adatai

Ki végzi

AstraZeneca

Azonosító

NCT07391657

A regiszteradat frissítve

2026. szeptember 29.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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.

Bevonási feltételek: Age ≥ 18 years; Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria; Documented evidence of measurable disease:; Serum M-protein level ≥ 1 g/dL; Urine M-protein level ≥ 200 mg/24h; 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:; Haemoglobin ≥ 8.0 g/dL; Absolute neutrophil count ≥ 1 × 10\^9/L (1000 per mm3); 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; Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L); 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.

Kizáró feltételek: Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM; Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy); 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; Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome; Significant neurological or psychiatric condition; Significant medical condition that places the participant at an unacceptable risk for treatment-related complications.

ClinicalTrials.gov NCT07391657