Clinical Study of Universal CAR-γδT Cell Injection in the Treatment of Patients With Relapsed AML After Transplantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety: Incidence and severity of adverse events
研究概览
简要总结
This is an open single-arm clinical study aimed at evaluating the efficacy and safety of universal γδT cell injection in the treatment of patients with relapsed AML after transplantation
详细描述
Main purpose: To evaluate the safety and effectiveness of universal CAR-γδT cell injection in the treatment of patients with relapsed AML after transplantation
Secondary purpose: to investigate the in vivo dynamics characteristics of universal CAR-γδT cells after infusion and explore reasonable therapeutic doses through climbing tests in different dose groups.
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
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinically diagnosed recurrence of AML after receiving transplant therapy;
- •Flow cytometry (FCM) or immunohistochemical detection of tumor cells confirmed CD123 positive;
- •Age ≥2 years old and <65 years old;
- •Survival is expected to be greater than 3 months from the date of signing of the informed consent;
- •KPS 80 points or more;
- •The functions of vital organs shall meet the following conditions:
- •EF>50%, and no obvious ECG abnormality; 2) SpO2 90% or more; 3) Cr 2.5 ULN or less; 4) ALT And AST≤5ULN, TBil≤3ULN;
- •Subjects who plan to become pregnant must agree before study enrollment and after study duration of 6 months Use contraception; Inform the investigator immediately if the subject is pregnant or suspected to be pregnant;
- •Subject or guardian understands and signs the informed consent;
排除标准
- •Other diseases that have not been effectively controlled, including but not limited to persistent or poorly controlled infections and diseases Congestive heart failure, unstable angina pectoris, arrhythmias, poorly controlled lung disease Or mental illness;
- •Other active malignant tumors;
- •Complicated with severe infection that cannot be effectively controlled;
- •Active hepatitis B (HBVDNA) or HCV RNA [HCVRNA] test was positive);
- •Human immunodeficiency virus (HIV) infection or syphilis infection;
- •Have a history of severe allergy to biological products (including antibiotics);
- •Acute graft-versus-host reaction (GVHD) was still present one month after discontinuation of immunosuppressant therapy Allogeneic hematopoietic stem cell transplantation patients;
- •Female subjects are in pregnancy and lactation;
- •Active autoimmune diseases requiring systemic immunosuppression;
- •Conditions that the investigator believes may increase the risk of the subject or interfere with the results of the test;
结局指标
主要结局
Safety: Incidence and severity of adverse events
时间窗: First 1 month post CAR-T cells infusion
To evaluate the possible adverse events occurred within first one month after CAR-γδT infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Efficacy: Remission Rate
时间窗: 3 months post CAR-T cells infusion
Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
次要结局
- duration of response (DOR)(24 months post CAR-T cells infusion)
- CAR-T proliferation(3 months post CAR-T cells infusion)
- Efficacy: progression-free survival (PFS)(24 months post CAR-T cells infusion)
- Cytokine release(First 1 month post CAR-T cells infusion)