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CD7 CAR-T Bridging to alloHSCT for Severe Aplastic Anemia

RecruitingEARLY Phase 1Ages any - anyAllZhejiang University
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • CD7 CAR-T cells injection
  • Allogeneic hematopoietic stem cell transplantation
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Where

1 site
The First Affiliated Hospital of Zhejiang University School of Medicine
Hanzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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