NCT06633328招募中早期 1 期
Clinical Study on the Safety and Efficacy of Donor Derived CD7 CAR-T Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation for the for Patients With Severe Aplastic Anemia
Zhejiang University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with severe aplastic anemia
详细描述
This is a prospective, open-label, single-center clinical trial. This study will evaluate the safety and efficacy of CD7 CAR-T Bridging to allo-HSCT in the treatment of severe aplastic anemia.The primary endpoints are dose limiting toxicity (DLT) and the incidence of treatment emergent adverse event (TEAE).
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese expert consensus on the diagnosis and treatment of aplastic anemia（2017）, Diagnosis of severe aplastic anemia ，
- •The degree of bone marrow cell proliferation < 25%, or 25%-50% but residual hematopoietic cells < 30%；
- •With pancytopenia (at least two of the following peripheral blood parameters) : (1) absolute neutrophil <0.5×10^9/L; (2) Platelet count< 20×10^9/L; (3) The absolute value of reticulocytes <20×109/L;
- •Suitable donors (relatives) with allogeneic HSCT indications and at least haploid allogeneic transplantation;
- •Patients who are not suitable or unwilling to undergo traditional allogeneic hematopoietic stem cell transplantation;
- •creatinine clearance > 60ml/min; without liver invasion, serum total bilirubin ≤ 1.5 times the upper limit of normal, and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were both ≤ 3 times the upper limit of the normal range. If there is liver invasion, serum erythrambirubin ≤ 3 times the upper limit of normal, and serum ALT and AST are both ≤ 5 times the upper limit of the normal range;
- •Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
- •No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
- •Estimated survival time ≥ 3 months;
- •ECOG performance status 0 to 1;
- •Females and males of childbearing potential must agree to use adequate contraception prior to study entry, during study participation, and for 6 months after infusion (the safety of this therapy for unborn children is not known and has unknown risks);
- •Those who voluntarily participated in this trial and provided informed consent;
排除标准
- •Allergy to pre-treatment measures；
- •Those with acute graft versus host disease (GvHD) or moderate to severe chronic GvHD within 4 weeks before screening; Those who have received systemic drug therapy for GvHD within 4 weeks before the reinfusion；
- •History of epilepsy or other central nervous system disorders；
- •Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- •Less than 100 days after allogeneic hematopoietic stem cell transplantation；
- •Patients with HIV infection，Active infection of hepatitis B virus or hepatitis C virus，Uncured active infection；
- •The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- •Received anti-cancer chemotherapy or other drug treatment within 2 weeks prior to screening;
- •Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the study.
研究组 & 干预措施
Treatment Group
Experimental
Aplastic Anemia
干预措施: CD7 CAR-T cells injection (Drug)
Treatment Group
Experimental
Aplastic Anemia
干预措施: Allogeneic hematopoietic stem cell transplantation (Other)
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
- Allogeneic hematopoietic stem cell transplant implantation rate(Up to 100 days after Treatment)
- Time to neutrophil and platelet engraftment(Up to 30 days after Treatment)
- Disease-feesurvival，DFS(Up to 2 years after Treatment)
- Overall survival, OS(Up to 2 years after Treatment)
研究者
He Huang
Clinical Professor
Zhejiang University
研究点 (1)
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