The Safety and Efficay Investigation of IL-5 CAR-T Cell Therapy for Patients With Refractory/Relapsed Eosinophilic Leukemia
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
- Dose-limiting toxicity (DLT)
研究概览
简要总结
This is an open-label, single-arm clinical study designed to evaluate the efficacy and safety of IL-5 CAR-T cell therapy in the treatment of patients with CD125-positive eosinophilic leukemia.
详细描述
The IL-5 CAR is composed of full length human IL-5 (hIL-5) fused to the human CD8α hinge and transmembrane domains, followed by the human 4-1BB co-stimulatory domain and the CD3ζ signaling domain. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.
The Main research objectives:
To evaluate the safety and efficacy of IL-5 CAR-T cells in patients with CD125-positive eosinophilic leukemia.
The Secondary research objectives:
To investigate the cytokinetic characteristics of IL-5 CAR-T cells in patients with CD125-positive eosinophilic leukemia.
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.Male or female patients aged ≥18 years;
- •2.Diagnosis of eosinophilic leukemia (EL) established according to the WHO 2022 diagnostic criteria;
- •3.Interleukin-5 receptor α (IL-5Rα, CD125) is expressed on ≥50% of leukemic blasts.
- •4.Meet any of the following criteria for refractory/relapsed eosinophilic leukemia:
- •a) Inadequate response to standard therapy: failure to achieve complete remission (CR) after standard treatments (e.g., imatinib, corticosteroids, interferon-α, chemotherapy, etc.);
- •b) Disease progression/relapse within 6 months after achieving remission;
- •5.Serum total bilirubin ≤1.5 × the upper limit of normal (ULN), and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN;
- •6.Left ventricular ejection fraction (LVEF) >50% as assessed by echocardiography;
- •7.Peripheral oxygen saturation (SpO₂) ≥92% on room air (without supplemental oxygen);
- •8.Estimated life expectancy >3 months;
- •9.Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- •10.Women and men of childbearing potential must agree to use appropriate, effective contraception prior to study entry, throughout the study period, and for 6 months after cell infusion (the safety of this therapy for unborn children is unknown and may pose potential risks);
- •11.Patients who are willing to participate in this study and who are able to understand and voluntarily sign the written informed consent form.
排除标准
- •1.History of epilepsy or other central nervous system (CNS) disorders;
- •2.Presence of any of the following:Hepatitis B surface antigen (HBsAg)-positive; Any of HBeAg, HBeAb, or HBcAb positive and detectable hepatitis B virus (HBV) DNA in peripheral blood above the lower limit of detection; Hepatitis C virus (HCV) antibody-positive; Human immunodeficiency virus (HIV) antibody-positive; Positive serologic test for syphilis;
- •3.History of QT interval prolongation or severe cardiac disease;
- •4.Presence of uncontrolled active infection;
- •5.Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the interpretation of the study results.
研究组 & 干预措施
CAR-T cells
IL-5 CAR-T cells
干预措施: IL-5 CAR-T cells (Drug)
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
Clinical Professor
Zhejiang University