Clinical trial NCT06864598: The Application of Novel Identified CD8 Regulatory Precursors in Inducing Immune Tolerance After Allo-HSCT
Official title: The Application of Novel Identified CD8 Regulatory Precursors in Inducing Immune Tolerance After Allogenic Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Graft-versus-host Disease (GVHD)
Keywords: allogeneic hematopoietic stem cell transplantation
Graft-versus-host disease
CD8 regulatory precursor
immune tolerance
immunomodulatory
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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?


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.

Primary outcomes:
measure: Proportion of CD8 Trp subgroups
timeFrame: From enrollment to 2-year follow-up
Secondary outcomes:
measure: T-cell function
timeFrame: From enrollment to 2-year follow-up
measure: T-cell activation
timeFrame: From enrollment to 2-year follow-up
measure: T-cell subset
timeFrame: From enrollment to 2-year follow-up
measure: T Cell exhaustion
timeFrame: From enrollment to 2-year follow-up
measure: Thymic output
timeFrame: From enrollment to 2-year follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: No. 11 Xizhimen South Street, Xicheng District, Beijing, China
state: Beijing
Study officials:
References: