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Clinical Trials in China / NCT06864598
Enrolling by invitation Observational

The Application of Novel Identified CD8 Regulatory Precursors in Inducing Immune Tolerance After Allo-HSCT

NCT06864598 · tracked via the Priya Life Science China tracker
Sponsor
Peking University People's Hospital
Phase
Observational
Started
2025-01-09
Last updated
2025-03-07

Condition(s) studied

Graft-versus-host Disease (GVHD)

Study summary

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the most effective treatment for acute leukaemia. The reconstitution of the recipient's immune system with donor-derived HSCT cells and the development of immune tolerance are critical to the success of HSCT. Patients who fail to establish immune tolerance after transplantation develop graft-versus-host disease (GVHD), which is a serious threat to patients' lives and quality of life.

Utilising single-cell multi-omics sequencing technology, the study's principal investigator elucidated the distribution of immune cell subpopulations in patients who successfully established immune tolerance post-transplantation. This research also identified a novel group of CD8 regulatory precursors (CD8 Trps), confirming their critical regulatory role in inducing immune tolerance in post-transplantation patients. This finding suggests that this subpopulation may serve as a novel target for predicting and intervening in GVHD. The successful implementation of this project will establish a new method for early prediction of GVHD and provide a new strategy for clinical intervention of GVHD.

The goal of this observational study is to explore the sensitivity and validity of the CD8 Trps as a novel biomarker molecule for predicting the development of GVHD through a prospective clinical cohort. The main question it aims to answer is:

Can the CD8 Trps serve as an effective molecular marker for the prediction of GVHD occurrence? Can the CD8 Trps cell serve as a novel strategy for GVHD intervention?

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Patients proposed for allogeneic haematopoietic stem cell transplantation; 2. Age 18\~60 years old; 3. All enrolled patients need to sign an informed consent. Exclusion Criteria: 1. Patients with type of transplantation as unrelated or cord blood transplantation; 2. lack of patient compliance.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
No. 11 Xizhimen South Street, Xicheng District, Beijing, China Beijing Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06864598 on ClinicalTrials.gov ↗ ← All trials in China