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

NCT06864598 | Enrolling By Invitation

• 1 other identifier: 2025PHB050-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Keywords

allogeneic hematopoietic stem cell transplantation; Graft-versus-host disease; CD8 regulatory precursor; immune tolerance; immunomodulatory

Outcome Measures

Primary Outcomes (1)

• Proportion of CD8 Trp subgroups

  Healthy donor samples will be collected at the onset of the project, and peripheral blood specimens from patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) will be serially assessed at 90 days, 180 days, 365 days, and 2 years post-transplantation. In this study, flow cytometry will be utilized to analyse the proportions and absolute numbers of CD8Trp in the peripheral blood of healthy donors and transplant recipients by combining markers such as CD3、CD4、CD8、HLA-DR、CD27、CD45RA、CCR7、CD28、ICOS、FOXP3、TCF1.

  From enrollment to 2-year follow-up

Secondary Outcomes (5)

• T-cell function

  From enrollment to 2-year follow-up

• T-cell activation

  From enrollment to 2-year follow-up

• T-cell subset

  From enrollment to 2-year follow-up

• T Cell exhaustion

  From enrollment to 2-year follow-up

• Thymic output

  From enrollment to 2-year follow-up

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

About 100 patients to be recruited for allogeneic hematopoietic stem cell transplantation in the Department of Hematology, People's Hospital of Peking University, Peking, China, from January 2025 to January 2026 are proposed to be recruited.

You may qualify if:

• Patients proposed for allogeneic haematopoietic stem cell transplantation;
• Age 18\~60 years old;
• All enrolled patients need to sign an informed consent.

You may not qualify if:

• Patients with type of transplantation as unrelated or cord blood transplantation;
• lack of patient compliance.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100035, China

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 7, 2025
• Study Start: January 9, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)