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

NCT04004637 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-09-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • PersonGen BioTherapeutics (Suzhou) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-25
Primary Completion
2021-06-01
Completion
2021-06-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04004637 on ClinicalTrials.gov