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The Clinical Study of CD20 CAR-T Cells in Patients With Relapsed and Refractory B Cell Non-Hodgkin Lymphoma

NCT04169932 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-11-20

No results posted yet for this study

Summary

This is a single arm, open-label study to evaluate the safety, tolerance and efficacy of CD20 CAR-T Cells in patients with relapsed and refractory B cell non-Hodgkin Lymphoma. Subjects receive a single intravenous infusion of CD20-CART cells per treatment course.

Conditions

Interventions

BIOLOGICAL

CD20 CAR-T

The maximum dose was determined according to the dose escalation test. Based on the number of CART cells per kg body weight which was proved to be safe and effective, all the subjects were treated with one single dose of CD20 CART cells per treatment course. The dose escalation test was designed to evaluate the four dose levels of CD20-CART (1 × 10 \^ 6 cells/kg,2 × 10 \^ 6 cells/kg,4 × 10 \^ 6 cells/kg,8 × 10 \^ 6 cells/kg).

Sponsors & Collaborators

  • Shanghai Longyao Biotechnology Inc., Ltd.

    lead OTHER

Principal Investigators

  • Yi Yao, ph.D · Shanghai Longyao Bio-Tech Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-11-22
Primary Completion
2022-11-22
Completion
2022-11-22

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04169932 on ClinicalTrials.gov