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RECRUITING
NCT05210907
PHASE1

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

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

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.

Official title: A Phase Ib, Clinical Trial of Hospital-manufactured CD19 Chimeric Antigen Receptor T Cells (SNUH-CD19-CAR-T) in Children and Adolescents With Relapsed or Refractory CD19 Positive Acute Lymphoblastic Leukemia

Key Details

Gender

All

Age Range

0 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2022-02-15

Completion Date

2026-08-31

Last Updated

2023-02-06

Healthy Volunteers

No

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.

Locations (1)

Seoul National University Hospital

Seoul, South Korea