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Graft-versus-host Disease (GVHD)NCT06864598

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

An observational study of Graft-versus-host Disease (GVHD), run by Peking University People's Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Graft-versus-host Disease (GVHD)
How many people
100 participants
Where
1 siteChina
Study dates
9 Jan 2025to 31 Oct 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

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

    Beijing, Beijing Municipality, 100035

Other trials in China

About this study

Official title: The Application of Novel Identified CD8 Regulatory Precursors in Inducing Immune Tolerance After Allogenic Hematopoietic Stem Cell Transplantation

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.

Read more

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?

Keywords
allogeneic hematopoietic stem cell transplantation, Graft-versus-host disease, CD8 regulatory precursor, immune tolerance, immunomodulatory
Medical subject headings
Graft vs Host Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to 2-year follow-up

Secondary outcomes (5)

  1. T-cell function

    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. Peripheral blood T cells will be isolated and subjected to in vitro stimulation using either CD3/CD28 beads or the pharmacological agents phorbol 12-myristate 13-acetate (PMA) and ionomycin. Following stimulation, the production of cytokines will be assessed, including but not limited to IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ, CD107A , Perforin and Granzyme B.

    Measured: From enrollment to 2-year follow-up

  2. T-cell activation

    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. The activation markers CD25, CD38, CD69, CD137, CD71, and HLA-DR, among others, will be detected via flow cytometry to evaluate the activation status of T cells in the peripheral blood of both healthy donors and transplant recipients.

    Measured: From enrollment to 2-year follow-up

  3. T-cell subset

    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. This study will employ flow cytometry to quantify the proportions of various T-cell subpopulations in the peripheral blood of healthy donors and transplant recipients, including recent thymic emigrants (RTE), naive T cells, central memory T cells (TCM), effector memory T cells (TEM), terminally differentiated effector memory T cells (TEMRA), and regulatory T cells (Tregs).

    Measured: From enrollment to 2-year follow-up

  4. T Cell exhaustion

    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. T-cell exhaustion will be evaluated through the analysis of a range of specific markers, including PD-1, TIGIT, LAG-3, TIM-3, and associated molecules.

    Measured: From enrollment to 2-year follow-up

  5. Thymic output

    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. The functional status of thymic output will be comprehensively evaluated by detecting CD31, CD38, and CD103 markers in peripheral blood using flow cytometry. Additionally, the level of sjTREC (Signal Joint T-Cell Receptor Excision Circle) will be measured to further illustrate the functional capacity of thymic output.

    Measured: From enrollment to 2-year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2025
  2. Study start9 Jan 2025
  3. Primary completion1 Feb 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06864598
Sponsor's protocol ID
2025PHB050-001
Status last verified
Feb 2025
First submitted
21 Feb 2025
Last updated
7 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Graft-versus-host Disease (GVHD), run by Peking University People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of CD8 Trp subgroups (time frame: From enrollment to 2-year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06864598.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.

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