NCT06423131

Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT

TCRαβ+ Cell Deleted Versus Traditional Haploidentical Hematopoietic Stem Cell Transplantation ：A Single-center, Prospective, Non-randomized Controlled Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Sijia Gu · Academic / Other
• Sex: All
• Age: 8 Weeks – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center prospective, non-randomized controlled clinical study in China using CliniMACS TCRα/β+ cell depleted stem cell haploidentical donors versus conventional Beijing protocol for haploidentical hematopoietic stem cell transplantation in children.

Detailed description

1:1 non-randomized controlled clinical study in single center using CliniMACS TCRα/β+ cell depleted stem cell versus conventional Beijing protocol for haploidentical hematopoietic stem cell transplant. The purpose of this study is to obtain 30% decrease grade II-IV aGVHD and better qulity of life for TCRα/β+ cell depleted haploidentical stem cell transplantaion.

Conditions

• Graft-Versus-Host Disease
• Hematopoietic Stem Cell Transplantation
• Child, Only
• Haploidentical Hematopoietic Stem Cell Transplantation

Interventions

Type	Name	Description
PROCEDURE	TCRαβ Depleted haploidentical HCT	Use the CliniMACS TCRα/β deplete from the mobilized peripheral blood stem cells of haploidentical donor in children

Timeline

• Start date: 2024-05-26
• Primary completion: 2027-03-31
• Completion: 2028-03-31
• First posted: 2024-05-21
• Last updated: 2024-05-29

Locations

1 site across 1 country: China