RecruitingPhase 1NCT05210907

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

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


Sponsor

Seoul National University Hospital

Enrollment

5 participants

Start Date

Feb 15, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 0 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy — a treatment where your own immune cells are genetically modified to hunt and kill leukemia cells — for children and young adults with acute lymphoblastic leukemia (ALL) that has come back or did not respond to standard treatment. The CAR-T cells are made at the hospital specifically targeting a marker called CD19 on leukemia cells. **You may be eligible if...** - You are younger than 26 years old - You have CD19-positive ALL that has relapsed (come back) or did not respond to chemotherapy - You have experienced a second or later bone marrow relapse, relapse after a stem cell transplant, or cannot receive a stem cell transplant - You are in a reasonable physical condition (Karnofsky/Lansky score of at least 50) **You may NOT be eligible if...** - You have uncontrolled hepatitis B or C - You have a known HIV infection - You have an active, uncontrolled infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALSNUH-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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05210907


Related Trials