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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06423131

Enrollment

110

Registered

2024-05-21

Start date

2024-05-26

Completion date

2028-03-31

Last updated

2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

PROCEDURETCRαβ Depleted haploidentical HCT

Use the CliniMACS TCRα/β deplete from the mobilized peripheral blood stem cells of haploidentical donor in children

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

TCRαβ depleted HSCT compare to traditional Beijing haploidentical HSCT

Eligibility

Sex/Gender

ALL

Age

8 Weeks to 18 Years

Healthy volunteers

Inclusion criteria

* Age 8 weeks to 18 years * Children who meet the indicators haploidentical hematopoietic cell transplantation * No HLA ≥ 9/10 donor or not suitable for this type of donor due to illness * Informed consent must be signed (by the patient or legal representative)

Exclusion criteria

* Liver function abnormalities with bilirubin \>2 mg/dL and elevation of transaminases higher than 400 U/L * Chronic active viral hepatitis * Ejection fraction \<50% * Respiratory failure necessitating supplemental oxygen * Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study * Patients unwilling or unable to comply with the protocol or unable to give informed consent * Concurrent severe or uncontrolled infection

Design outcomes

Primary

Measure	Time frame	Description
Incidence of grade II-IV acute GVHD	day+100	Incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation.
incidence of treatment related mortality(TRM)	day +100	compare the incidence of TRM until Day 100 post-transplantation

Secondary

Measure	Time frame	Description
post HSCT day 1y and 2y GRFS and OS	day +1y and +2y	compare the incidence of GRFS and OS post HSCT 1y and 2y
cGVHD post day 1y and 2y	day +1y and +2y	compare the incidence of cGVHD post HSCT 1y and 2y
TRM post day +1y and +2y	day +1y and +2y	compre the incidence of TRM post HSCT day 1y and 2y

Countries

China

Contacts

Primary ContactJing Chen, PhD

chenjing@scmc.com.cn38626161

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026