This study is designed to explore the safety and efficacy of CD7 CAR-T Cells for patients with relapse/refractory CD7+ NK/T cell lymphoma ,T-lymphoblastic lymphoma and Acute Lymphocytic Leukemia. And to evaluate the pharmacokinetics of CD7 CAR-T cells in patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Biological: CD7 CAR-T cells infusion. Pretreatment: patients enrolled in this study will receive cyclophosphamide or fludarabine plus cyclophosphamide. CD7 CAR-T cells infusion are allowed within 2 weeks after treatment. CD7 CAR-T cells infusion: 30-60 minutes before infusion, H1 anti-histamine agents are applied (acetaminophen 30mg,po.; promethazine 25mg,i.v. ; diphenhydramine 0.5-1mg/kg, no more than 50mg.). Non-physiological doses of corticosteroids are not applied for patients during treatment or recovery unless a life-threatening emergency occurs. CD7 CAR-T cells are infused into patients for one or two times, the number of infused CD7 CAR-T cells are 0.5-5×10\^6/kg.
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGIdentification of the dose limiting toxicity (DLT)
Toxicity will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale, version 5 and the number of patients experiencing DLT will be evaluated.
Time frame: Time Frame: 4 weeks after CAR T cell infusion
In vivo persistence/expansion of infused CAR T cell
Detection of infused CAR T cell in the peripheral blood.
Time frame: Up to 2 years
Determine the effects of CART-CD7 infusion on T cells and CD7 expression in vivo.
Time frame: Up to 2 years
Overall Response Rate (ORR)
Time frame: 4 weeks after CAR T cell infusion
Overall Survival
Time frame: Up to 2 years
Disease-free survival
Time frame: Up to 2 years
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