NCT04004637

CD7 CAR-T Cells for Patients With R/R CD7+ NK/T Cell Lymphoma,T-lymphoblastic Lymphoma and Acute Lymphocytic Leukemia

CD7 CAR-T Cells for Patients With Relapse/Refractory CD7+ NK/T Cell Lymphoma ,T-lymphoblastic Lymphoma and Acute Lymphocytic Leukemia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 7 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• T-lymphoblastic Lymphoma
• NK/T Cell Lymphoma
• Acute Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	CD7 CAR-T cells infusion	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.

Timeline

• Start date: 2019-08-25
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2019-07-02
• Last updated: 2020-09-28

Locations

1 site across 1 country: China