The Application of Novel Identified CD8 Regulatory Precursors in Inducing Immune Tolerance After Allo-HSCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Graft-versus-host Disease (GVHD). Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Application of Novel Identified CD8 Regulatory Precursors in Inducing Immune Tolerance After Allogenic Hematopoietic Stem Cell Transplantation
Overview
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?
Primary outcome measures
- Proportion of CD8 Trp subgroups [Time frame: From enrollment to 2-year follow-up]
Secondary outcome measures (5)
- T-cell function [Time frame: From enrollment to 2-year follow-up]
- T-cell activation [Time frame: From enrollment to 2-year follow-up]
- T-cell subset [Time frame: From enrollment to 2-year follow-up]
- T Cell exhaustion [Time frame: From enrollment to 2-year follow-up]
- Thymic output [Time frame: From enrollment to 2-year follow-up]
Eligibility criteria
Inclusion criteria
- Patients proposed for allogeneic haematopoietic stem cell transplantation;
- Age 18\~60 years old;
- All enrolled patients need to sign an informed consent.
Exclusion criteria
- Patients with type of transplantation as unrelated or cord blood transplantation;
- lack of patient compliance.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- No. 11 Xizhimen South Street, Xicheng District, Beijing, China — Beijing
Identifiers
NCT: NCT06864598 · 2025PHB050-001