NCT06423131 Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT
| NCT ID | NCT06423131 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sijia Gu |
| Condition | Graft-Versus-Host Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-05-26 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2024-05-26 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Jing Chen, PhD
PRINCIPAL INVESTIGATOR
Shanghai Children's Medical Center
Frequently Asked Questions
Who can join the NCT06423131 clinical trial?
This trial is open to participants of all sexes, aged 8 Weeks or older, up to 18 Years, studying Graft-Versus-Host Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06423131 currently recruiting?
Yes, NCT06423131 is actively recruiting participants. Contact the research team at chenjing@scmc.com.cn for enrollment information.
Where is the NCT06423131 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06423131 clinical trial?
NCT06423131 is sponsored by Sijia Gu. The principal investigator is Jing Chen, PhD at Shanghai Children's Medical Center. The trial plans to enroll 110 participants.