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

NCT ID: NCT06864598

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-09
• Study Completion Date: 2026-10-31

Brief 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?

Conditions

Graft-versus-host Disease (GVHD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiao-Jun Huang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2025PHB050-001

Identifier Type: -

Identifier Source: org_study_id