RecruitingEarly Phase 1NCT06633328

CD7 CAR-T Bridging to alloHSCT for Severe Aplastic Anemia

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

Sponsor

Zhejiang University

Enrollment

30 participants

Start Date

Oct 20, 2024

Study Type

INTERVENTIONAL

Conditions

Aplastic Anemia

Summary

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

Eligibility

Inclusion Criteria10

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 Criteria9

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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Interventions

DRUGCD7 CAR-T cells injection

CD7 CAR T cells treat patients with severe aplastic anemia

OTHERAllogeneic hematopoietic stem cell transplantation

In this study, Allogeneic hematopoietic stem cell transplantation is used as a bridge therapy to CD7 CAR T cells infusion to treat patients with severe aplastic anemia