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CD19 CAR-T Cells With CRS Suppression Technology for r/r CD19+ Acute Lymphoblastic Leukemia

NCT03275493 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-05-28

No results posted yet for this study

Summary

This is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of T cells expressing CD19 chimeric antigen receptors treatment for relapsed/refractory CD19+ acute lymphoblastic leukemia patients.

Conditions

Interventions

BIOLOGICAL

CD19 CAR-T cells

Express a Second Generation 4-1BB: CD19 CAR-T cells

BIOLOGICAL

CD19 CAR-T cells with CRS suppression technology

Express a Second Generation 4-1BB:CD19 CAR-T cells with CRS suppression technology

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    collaborator OTHER

  • Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Xiaowen Tang, PhD · The First Affiliated Hospital of Soochow University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2024-12-31
Completion
2025-12-31

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 NCT03275493 on ClinicalTrials.gov