CD7 CAR-T Bridging to alloHSCT for Severe Aplastic Anemia

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

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).

Eligibility Criteria:
Inclusion Criteria:

* Chinese expert consensus on the diagnosis and treatment of aplastic anemia（2017）, Diagnosis of severe aplastic anemia ，1. The degree of bone marrow cell proliferation \< 25%, or 25%-50% but residual hematopoietic cells \< 30%；2. 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;

Exclusion Criteria:

* 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.