2025-523285-25-00招募中3 期
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)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 153
- 试验地点
- 43
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
DARZALEX 1800 mg solution for injection
Comparator
干预措施: DARZALEX 1800 mg solution for injection (Drug)
Bortezomib Hikma 3,5 mg Pulver zur Herstellung einer Injektionslösung
Comparator
干预措施: Bortezomib Hikma 3,5 mg Pulver zur Herstellung einer Injektionslösung (Drug)
Kyprolis 10 mg powder for solution for infusion, Kyprolis 30 mg powder for solution for infusion, Kyprolis 60 mg powder for solution for infusion
Comparator
干预措施: Kyprolis 10 mg powder for solution for infusion (Drug)
Kyprolis 10 mg powder for solution for infusion, Kyprolis 30 mg powder for solution for infusion, Kyprolis 60 mg powder for solution for infusion
Comparator
干预措施: Kyprolis 30 mg powder for solution for infusion (Drug)
Pomalidomide Zentiva 1 mg hard capsules, Pomalidomide Zentiva 2 mg hard capsules, Pomalidomide Zentiva 3 mg hard capsules, Pomalidomide Zentiva 4 mg hard capsules
Comparator
干预措施: Pomalidomide Zentiva 4 mg hard capsules (Drug)
Kyprolis 10 mg powder for solution for infusion, Kyprolis 30 mg powder for solution for infusion, Kyprolis 60 mg powder for solution for infusion
Comparator
干预措施: Kyprolis 60 mg powder for solution for infusion (Drug)
Dexamethason 8 mg JENAPHARM®, Dexamethason 1,5 mg JENAPHARM®, Dexamethason 0,5 mg JENAPHARM®, Dexamethason 4 mg JENAPHARM
Comparator
干预措施: Dexamethason 8 mg JENAPHARM® (Drug)
Dexamethason 8 mg JENAPHARM®, Dexamethason 1,5 mg JENAPHARM®, Dexamethason 0,5 mg JENAPHARM®, Dexamethason 4 mg JENAPHARM
Comparator
干预措施: Dexamethason 1,5 mg JENAPHARM® (Drug)
Dexamethason 8 mg JENAPHARM®, Dexamethason 1,5 mg JENAPHARM®, Dexamethason 0,5 mg JENAPHARM®, Dexamethason 4 mg JENAPHARM
Comparator
干预措施: Dexamethason 0,5 mg JENAPHARM® (Drug)
Dexamethason 8 mg JENAPHARM®, Dexamethason 1,5 mg JENAPHARM®, Dexamethason 0,5 mg JENAPHARM®, Dexamethason 4 mg JENAPHARM
Comparator
干预措施: Dexamethason 4 mg JENAPHARM (Drug)
Pomalidomide Zentiva 1 mg hard capsules, Pomalidomide Zentiva 2 mg hard capsules, Pomalidomide Zentiva 3 mg hard capsules, Pomalidomide Zentiva 4 mg hard capsules
Comparator
干预措施: Pomalidomide Zentiva 1 mg hard capsules (Drug)
Pomalidomide Zentiva 1 mg hard capsules, Pomalidomide Zentiva 2 mg hard capsules, Pomalidomide Zentiva 3 mg hard capsules, Pomalidomide Zentiva 4 mg hard capsules
Comparator
干预措施: Pomalidomide Zentiva 2 mg hard capsules (Drug)
Pomalidomide Zentiva 1 mg hard capsules, Pomalidomide Zentiva 2 mg hard capsules, Pomalidomide Zentiva 3 mg hard capsules, Pomalidomide Zentiva 4 mg hard capsules
Comparator
干预措施: Pomalidomide Zentiva 3 mg hard capsules (Drug)
AZD0120
Test
干预措施: AZD0120 (Drug)
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (43)
Loading locations...
相似试验
招募中
2 期
A trial to learn how safe AZD3632 is, how well it works, and how it moves throughout the body over time in adults with acute leukemia and myelodysplastic syndrome with HOX gene overexpression2025-521299-76-00AstraZeneca AB1
招募中
2 期
Efficacy and Safety of APSTZD in the Treatment of Insomnia DisorderInsomniaNCT07420816Apsen Farmaceutica S.A.222
招募中
1 期
A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer DrugsProstate CancerNCT07336446AstraZeneca300
招募中
3 期
A study on Major Adverse cardiovascular events in Patients with a History of Atherosclerotic cardiovascular disease events or at High Risk for a First EventCTRI/2025/10/095916AstraZeneca AB15,100
招募中
1 期
CAR-T Therapy Targeting CD19 and BCMA in Highly Sensitized Kidney Transplant ParticipantsNCT07350837Tongji Hospital12