CD7 CAR-T Bridging to alloHSCT for Severe Aplastic Anemia
Key facts
- Where
- Hanzhou, ChinaSee the site
- Phase
- Early phase 1
Where in China
- The First Affiliated Hospital of Zhejiang University School of MedicineHanzhou, ChinaContact: He Huang, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Zhejiang University
- Trial code
- NCT06633328
- Record updated
- 9 October 2024
- Original description
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 anemiaRead full original descriptionShow less
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
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
Inclusion: 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: 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；; Less than 100 days after allogeneic hematopoietic stem cell transplantation；; Received anti-cancer chemotherapy or other drug treatment within 2 weeks prior to screening; Allergy to pre-treatment measures；; History of epilepsy or other central nervous system disorders；; Patients with HIV infection，Active infection of hepatitis B virus or hepatitis C virus，Uncured active infection；; Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the study; Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal.