NCT06247501

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Very High Risk Acute Lymphoblastic Leukemia
• CD19 CAR-T Therapy

Interventions

Type	Name	Description
GENETIC	SNUH-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.

Timeline

• Start date: 2024-01-19
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2024-02-08
• Last updated: 2024-02-08

Locations

1 site across 1 country: South Korea