RecruitingPhase 2NCT06247501

Treatment of CD19 Chimeric Antigen Receptor T Cells for Pediatric Patients With CD19-positive B-cell Acute Lymphoblastic Leukemia Who Are Indicated for Hematopoietic Stem Cell Transplantation

Sponsor

Seoul National University Hospital

Enrollment

50 participants

Start Date

Jan 19, 2024

Study Type

INTERVENTIONAL

Conditions

Very High Risk Acute Lymphoblastic Leukemia CD19 CAR-T Therapy

Summary

This is a phase 2 clinical trial targeting pediatric and adolescent patients diagnosed with CD19-positive B-ALL, considered very high-risk group. The study aims to administer CD19 CAR-T therapy as an alternative to hematopoietic stem cell transplantation in patients eligible for such transplantation. The trial includes patients aged 25 or younger.

Eligibility

Max Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study tests a special immune cell therapy called CAR-T cell therapy for children and young adults with a type of blood cancer called B-cell acute lymphoblastic leukemia (B-ALL) who need a stem cell transplant. The therapy reprograms the patient's own immune cells to attack cancer cells that carry a protein called CD19. **You may be eligible if...** - You are under 25 years old - You have been diagnosed with B-cell acute lymphoblastic leukemia - Your leukemia cells have tested positive for CD19 - You have achieved remission (less than 5% cancer cells in bone marrow) after chemotherapy - You are a candidate for a stem cell transplant **You may NOT be eligible if...** - You have active, uncontrolled infection - You have severe organ problems - Your cancer has not responded to chemotherapy 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

GENETICSNUH-CD19-CAR-T

CD19 CAR-T is a gene therapy that uses genetically modified autologous peripheral blood T-cells to target CD19 on the surface of B-cells. In this approach using CARs, lymphocytes are genetically manipulated, introducing the chimeric antigen receptor gene into the lymphocytes to combine the function of effector T-cells with antibody-like abilities. The chimeric antigen receptor can recognize cell surface antigens without the need for antigen processing. By using a single-chain variable fragment (scFv) antibody, which combines the variable regions of the heavy chain (VH) and light chain (VL) through a peptide linker of approximately 15 amino acids in length, the CAR gains the ability to bind to tumor antigens.

Locations(1)

Seoul National University Children's Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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

Visit

NCT06247501