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CD19-CART in the Treatment of R/R CD19 Positive Non-Hodgkin's Lymphoma

NCT04237428 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-01-23

No results posted yet for this study

Summary

To evaluate the safety and efficacy of targeted CD19 chimeric antigen receptor T cell infusion in the treatment of relapsed or refractory CD19 positive non-Hodgkin's lymphoma.

Conditions

  • Non Hodgkin Lymphoma

Interventions

BIOLOGICAL

CD19 CAR-T cells infusion

Biological: CD19 CAR-T cells infusion Biological: CD19 CAR-T cells infusion. Pretreatment: patients enrolled in this study will receive cyclophosphamide or fludarabine plus cyclophosphamide. CD19 CAR-T cells infusion are allowed within 2 weeks after treatment. CD19 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. CD19 CAR-T cells are infused into patients for one time, the number of infused CD19 CAR-T cells are 0.5-4×10\^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
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2019-06-15
Completion
2021-05-31

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 NCT04237428 on ClinicalTrials.gov