NCT07144020招募中1 期
Donor Derived CD117 CAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Zhejiang University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月5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
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
A Clinical Study on the Safety and Effectiveness of Donor Derived CD117 CAR-T Cell in the treatment of Relapsed/Refractory Acute Myeloid Leukemia
详细描述
This is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety and efficacy of CD117 CAR-T Cell in patients with relapsed or refractory acute myeloid leukemia. It is planned to enroll 15-50 participants in this trial.
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
- •1. Patients with a histologically or immunophenotypically confirmed diagnosis of CD117-positive Acute Myeloid Leukemia (AML).
- •2. Diagnosis must meet the 2016 WHO classification criteria for AML and fulfill the definitions for relapsed or refractory disease per the *Chinese Guidelines for the Diagnosis and Management of Relapsed/Refractory Acute Myeloid Leukemia (2017 Edition)*, with no available suitable standard therapeutic options or registered clinical trials.
- •a). Relapsed AML: Defined as the reappearance of leukemic blasts in the peripheral blood, bone marrow blast count >5% (when assessed morphologically, after excluding regenerative changes post-consolidation chemotherapy), or development of extramedullary disease after achieving a Complete Remission (CR).
- •b). Refractory AML (meeting at least one criterion): Failure to achieve CR following two cycles of standard induction therapy in newly diagnosed patients; relapse within 12 months after CR following consolidation therapy; relapse beyond 12 months that fails to respond to conventional salvage chemotherapy; ≥2 relapses; or persistent extramedullary leukemia.
- •3. Presence of >5% bone marrow blasts (by morphology) and/or >1% (by flow cytometric analysis).
- •4. Total bilirubin ≤1.5 × ULN (≤51 μmol/L) ALT and AST ≤3 × ULN Serum creatinine ≤1.5 × ULN (≤176.8 μmol/L)
- •5. Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiography.
- •6. Oxygen saturation ≥92% on room air.
- •7. Life expectancy ≥3 months.
- •8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or
- •9. For patients of childbearing potential: Agreement to use highly effective contraception from screening, throughout the study treatment period, and for at least 6 months after the cell infusion (due to unknown risks to the fetus).
- •10. Voluntary participation, understanding of the study procedures, and provision of written informed consent by the patient or their legally authorized representative.
排除标准
- •1. Patients with the history of epilepsy or other CNS disease;
- •2. Patients with prolonged QT interval time or severe heart disease;
- •3. Active infection with no cure;
- •4. Active infection of hepatitis B virus or C virus ;
- •5. Before using any gene therapy products;
- •6. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- •7. Suffering from other uncontrolled diseases that the researchers consider unsuitable for joining;
- •8. Infected with AIDS virus;
- •9. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.
研究组 & 干预措施
CAR-T cells（ chimeric antigen receptor T cells）
Experimental
Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
干预措施: CD117 CAR T-cells (Biological)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Up to 28 days after Treatment
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to 2 years after Treatment
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
次要结局
- Complete response (CR), and complete response with incomplete hematologic recovery (CRi)(Up to 12 weeks after CAR-T infusion)
- Duration of remission ,DOR(Up to 1 years after CAR-T infusion)
- Overall survival, OS(Up to 1 years after CAR-T infusion)
- Leukemia-Free Survival, LFS(Up to 2 years after Treatment)
研究者
He Huang
Principal Investigator
First Affiliated Hospital of Zhejiang University
研究点 (1)
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