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临床试验/NCT06633328
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

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

发起方
Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

He Huang

Clinical Professor

Zhejiang University

研究点 (1)

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