NCT07126782招募中1 期
Clinical Study on the Efficacy and Safety of Allogeneic γδ T Cells in the Treatment of Patients With MRD-positive Acute Myeloid Leukemia (AML) After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年7月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of allogeneic γδ T cells in patients with MRD-positive AML after allo-HSCT.
详细描述
This is a single-center, randomized, open label phase I clinical trial to evaluate the efficacy and safety of ex-vivo expanded allogeneic γδ T cells in patients with MRD-positive AML after allo-HSCT. The infusion doses of γδ T cells were 2E8 cells/kg and 4E8 cells/kg.
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
- •Patients should sign informed consent form voluntarily before the trail and comply with the requirements of this study.
- •Age≥18 years old, gender unlimited.
- •All the subjects met the 2016 WHO classification and were diagnosed with AML via MICM (Morphology,Immunophenotyping, Cytogenetics, and Molecular genetics).
- •AML patients receiving allo-HSCT.
- •Subjects classified into the favorable -to-intermediate risk group according to the 2022 European Leukemia Net (ELN) risk stratification guidelines.
- •All subjects were detected positive for MRD, and MRD was positive by flow cytometry (MFC) or/and positive for fusion genes/gene mutations by RQ-PCR.
- •ECOG performance status score: 0-
- •Inactive GVHD (acute GVHD grade II-IV or moderate to severe chronic GVHD).
- •Adequate bone marrow reserve, defined as: absolute neutrophil count (ANC) > 0.5E9/L and platelet count ≥20E9/L.
- •Adequate organ function as per protocol.
- •Male and female patients of reproductive potential must agree to use birth control during the study and for at least 28 days post study.
排除标准
- •Post-transplant relapse or extramedullary disease: AML patients post-allo-HSCT with ≥5% blasts in peripheral blood or bone marrow (excluding causes such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia infiltration.
- •Active GVHD: Subjects with active GVHD within 30 days before screening.
- •Active infections: HBV, HCV, HIV, syphilis (TP), active CMV, or EBV infection.
- •Neurological disorders: active autoimmune or inflammatory neurological diseases, clinically significant active cerebrovascular disease.
- •Unstable systemic diseases, including: unstable angina, cerebrovascular accident or transient ischemic attack (within 6 months before screening), myocardial infarction (within 6 months before screening), NYHA Class III/IV heart failure, refractory hypertension (defined as failure to control blood pressure despite lifestyle modifications and treatment with ≥4 antihypertensive drugs, including diuretics, for >1 month), clinically significant arrhythmias requiring medication, severe hepatic, renal, or metabolic disorders.
- •Major surgery: Subjects who underwent major surgery within 4 weeks before screening, as deemed ineligible by the investigator.
- •Concurrent non-hematologic malignancies.
- •Cardiac abnormalities, meeting any of the following: Left ventricular ejection fraction (LVEF) ≤45%. NYHA Class III/IV congestive heart failure. QTc interval >480 msec. Other cardiac conditions considered unsuitable by the investigator.
- •History of epilepsy or other active CNS disorders.
- •Uncontrolled infections: active systemic infections requiring treatment (e.g., sepsis, bacteremia, fungemia, tuberculosis, opportunistic infections).
- •Recent participation in other interventional trials: Subjects who participated in another interventional clinical study within 30 days prior to enrollment.
- •Other conditions: Any other circumstances deemed by the investigator to compromise subject safety or trial integrity.
研究组 & 干预措施
Allogeneic γδ T cell immunotherapy
Experimental
Patients will receive at least 4 cycles of in vitro extended allogeneic γδ T cell therapy, twice a week.
干预措施: Ex-vivo expanded allogeneic γδ T cells (Biological)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 4weeks
Defined as the MRD-negative complete remission rate (CRMRD- rate) at 4 weeks, representing the proportion of subjects achieving MRD negativity after 4 weeks of treatment.
次要结局
- MRD-negative rate at 2 weeks (CRMRD- rate)(2weeks)
- 2-Year Overall Survival (OS)(2 years)
- Duration of Response (DOR)(4weeks)
- Safety observation(Baseline to 2 years)
研究者
研究点 (1)
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