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Human CD19 Targeted T Cells Injection Therapy for Relapsed and Refractory CD19-positive Leukemia

NCT03798509 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-08-31

No results posted yet for this study

Summary

To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive B-cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.

Conditions

Interventions

DRUG

Human CD19 targeted T Cells Injection

Autologous genetically modified anti-CD19 CAR transduced T cells

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Hrain Biotechnology Co., Ltd.

    lead INDUSTRY

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
2019-03-13
Primary Completion
2022-01-31
Completion
2024-01-31

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 NCT03798509 on ClinicalTrials.gov