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Clinical Study of Hospital-manufactured CD19 CAR-T in Children and Adolescents With Acute Lymphoblastic Leukemia

NCT05210907 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-02-06

No results posted yet for this study

Summary

Chimeric antigen receptor T cells (CAR-T cells) have been developed to treat relapsed and refractory hematological malignancies with promising outcome in patients with very poor prognosis. The purpose of this clinical study is to produce the CD19\[cluster of differentiation antigen 19\] CAR-T (SNUH-CD19-CAR-T) at the investigational site and to evaluate safety and efficacy of SNUH-CD19-CAR-T in children and adolescent with relapsed/refractory B-cell acute lymphoblastic leukemia.

Conditions

Interventions

BIOLOGICAL

SNUH-CD19-CAR-T

SNUH-CD19-CAR-T is an autologous CAR-T from T cells collected from each patient. Administer a single dose of SNUH-CD19-CAR-T to patients with relapsed or refractory CD19 positive B-cell acute lymphoblastic leukemia, and evaluate safety and efficacy of SNUH-CD19-CAR-T for 12 months after the infusion.

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2025-09-30
Completion
2026-08-31

Countries

  • South Korea

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 NCT05210907 on ClinicalTrials.gov