NCT07073547招募中1 期
A Modular, Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120, a Dual-targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19 in Participants With Multiple Myeloma (DURGA-2)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 40
- 试验地点
- 13
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
This is an interventional, modular, open-label, multicenter study to primarily evaluate the safety and tolerability of AZD0120 in adult participants with multiple myeloma (MM).
详细描述
This modular study aims to evaluate the safety, tolerability, cellular kinetics, pharmacodynamic effect, immunogenicity, and preliminary efficacy of AZD0120 in subjects with newly diagnosed or early relapsed or primary refractory multiple myeloma. Module 1 consists of early line MM (including newly diagnosed MM and early relapsed or primary refractory MM) with AZD0120 (for newly diagnosed multiple myeloma (NDMM), the intervention is with AZD0120 ± maintenance). Module 2 consists of NDMM with AZD0120 ± maintenance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥18 years of age at the time of consent
- •Type of Participant and Disease Characteristics:
- •Participant must have documented diagnosis of MM per IMWG diagnostic criteria
- •ECOG performance status of 0 or
- •Adequate organ and bone marrow function.
- •For NDMM participants:
- •Participants on Module 1: Newly diagnosed multiple myeloma (NDMM) without prior anti- myeloma therapy (no more than 2 cycles of induction therapy before enrollment are acceptable)
- •For participants on Module 2: Newly diagnosed MM with a minimum of 4 cycles and a maximum of 6 cycles of induction therapy completed prior to screening
- •Classified as high-risk MM
- •For Early Relapsed or Primary Refractory MM (1 or 2 prior lines of therapy) participants:
- •Have received and failed 1 or 2 lines of anti-myeloma therapy
- •Have received a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) as part of their previous therapy
- •Have documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria within 1 year of starting treatment, or on or within 6 months of completing treatment of the subject's last line of anti-myeloma therapy, or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen
排除标准
- •Have received prior treatment with CAR T therapy directed at any target
- •Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
- •Active or history of plasma cell leukemia at the time of screening
- •Seropositive for human immunodeficiency virus (HIV)
- •Active Hepatitis B infection
- •Active Hepatitis C infection
- •Serious underlying medical condition
研究组 & 干预措施
AZD0120
Experimental
AZD0120 will be administrated in one infusion
干预措施: AZD0120 (Biological)
结局指标
主要结局
Adverse Events (AEs)
时间窗: 2 years
Incidence and severity of adverse events (AEs)
Serious Adverse Events (SAEs)
时间窗: 2 years
Incidence and severity of serious adverse events (SAEs)
Dose Limiting Toxicities (DLT)
时间窗: 28 days
Incidence of dose limiting toxicities events
次要结局
- Pharmacokinetic - Cmax(2 years)
- Pharmacokinetic - Tmax(2 years)
- Pharmacokinetic - Clast(2 years)
- Pharmacokinetic - Tlast(2 years)
- Pharmacokinetic - Quantification of CAR transgene levels(2 years)
- Efficacy - Objective Response Rate (ORR)(2 years)
- Efficacy - Time to Response (TTR)(2 years)
- Humoral Immunogenicity(2 years)
- Module 2 Adverse Events (AEs) Maintenance(2 years)
- Module 2 Serious Adverse Events (SAEs) Maintenance(2 years)
- Efficacy - Complete Response Rate (CRR)(2 years)
- Pharmacokinetic - AUC0-28d(0-28 Days)
- Pharmacokinetic AUC0-3M(0 - 3 Months)
- Pharmacokinetic AUClast(2 years)
- Efficacy - Minimal Residual Disease (MRD) Negative CR Rate at 9 Months (± 3 months)(9 months)
- Efficacy - Sustained Minimal Residual Disease (MRD) Negative CR Rate(2 years)
- Efficacy - Duration of Response (DOR)(2 years)
研究者
研究点 (13)
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