NCT07198867招募中1 期
A Study of A-CAR028 Treatment in Subjects With Relapsed/ Refractory Acute Myeloid Leukemia
First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年9月30日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of dose limiting toxicities (DLTs)
研究概览
简要总结
This is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients
详细描述
The study includes the following sequential phases: Screening, Apheresis and A-CAR028 manufacturing, Baseline testing, Lymphodepletion, A-CAR028 infusion, Dose-limiting toxicity observation and Follow-up Visit
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years old at the time of signing the Informed Consent Form (ICF)
- •More than 12 weeks of expected survival
- •ECOG score 0 or 1
- •Relapsed or refractory AML
- •Adequate organ function
排除标准
- •Acute Promyelocytic Leukemia (APL)
- •Mixed Phenotype Acute Leukemia (MPAL)
- •Acute Undifferentiated Leukemia (AUL)
- •Only extramedullary leukemia
- •Known allergies to the components or excipients of the A-CAR028 cell product
- •Severe heart diseases, including but not limited to, myocardial infarction, angioplasty or stent implantation within 12 months prior to signing the ICF, unstable angina pectoris, severe arrhythmia, history of severe non-ischemic cardiomyopathy, heart failure
- •Autologous or allogeneic hematopoietic stem cell transplantation within 3 months prior to signing the ICF
- •Central nervous system (CNS) involvement or symptoms of CNS involvement (including cranial nerve lesions and extensive lesions or spinal cord compression)
- •A stroke or seizure occurred within 12 months prior to signing the ICF
- •Malignancy history within 5 years prior to signing the ICF
- •Uncontrolled active infection
- •Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive
- •Live vaccine injection within 4 weeks prior to signing the ICF
- •Acute or chronic graft-versus-host disease (GVHD) was present at screening
- •Inadequate washing time for previous treatment
- •Previously treated with CAR-T cell products or genetically modified T cell therapies
研究组 & 干预措施
A-CAR028
Experimental
Autologous A-CAR028 administered by intravenous (IV) infusion
干预措施: A-CAR028 (Biological)
结局指标
主要结局
Incidence of dose limiting toxicities (DLTs)
时间窗: Throughout the 28 days post A-CAR028 infusion
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
时间窗: Throughout the 3 months post A-CAR028 infusion
次要结局
- Incidence and severity of Adverse Events (AEs)(Throughout the 2 years post A-CAR028 infusion)
- Overall Response Rate (ORR): including Complete Response (CR), CR with Partial Hematologic Recovery (CRh), CR with Incomplete Hematologic Recovery (CRi), Morphologic Leukemia-free State (MLFS) and Partial Response (PR)(Throughout the 2 years post A-CAR028 infusion)
- Duration of Response (DOR)(Throughout the 2 years post A-CAR028 infusion)
- Event-free Survival (EFS)(Throughout the 2 years post A-CAR028 infusion)
- Overall Survival (OS)(Throughout the 2 years post A-CAR028 infusion)
- Maximal plasma concentration (Cmax)(Throughout the 2 years post A-CAR028 infusion)
- Time to reach the maximal plasma concentration (Tmax)(Throughout the 2 years post A-CAR028 infusion)
- Area under the curve within 28 days (AUC0-28d)(Throughout the 2 years post A-CAR028 infusion)
- Time of last measurable observed concentration (Tlast)(Throughout the 2 years post A-CAR028 infusion)
- Changes of CD33/CLL-1 positive cells in bone marrow(Throughout the 2 years post A-CAR028 infusion)
研究者
研究点 (1)
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