Early Clinical Study on the Use of Donor-derived EBV-specific T Cells for the Prevention of EBV Infection After Allogeneic Hematopoietic Stem Cell Transplantation

March 12, 2026 updated by: Institute of Hematology & Blood Diseases Hospital, China
This study is a single-arm, open-label, dose-escalation and expansion, prospective clinical trial. Subjects will be recipients of allogeneic hematopoietic stem cell transplantation, with a planned enrollment of 9 to 18 subjects, to evaluate the safety and efficacy of JYEST cell injection for the prevention of EBV infection after allogeneic hematopoietic stem cell transplantation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Inclusion criteria for allogeneic hematopoietic stem cell transplantation shall be implemented in accordance with the regulations of the transplant center at the study site;

  2. Patients undergoing allogeneic hematopoietic stem cell transplantation with any of the following high-risk factors for EBV infection:

    1. EBV-DNA is positive in the recipient's or donor's serum, whole blood, PBMC or sorted cells before allogeneic hematopoietic stem cell transplantation;
    2. EBV-DNA is positive in the recipient's whole blood, PBMC or sorted cells after allogeneic hematopoietic stem cell transplantation, but EBV-DNA in plasma is negative;
    3. Allogeneic hematopoietic stem cell transplantation is performed due to treatment of EBV infectious diseases, including but not limited to: EBV-related lymphoma, chronic active EBV infection, EBV-related lymphoproliferative disorders, etc.;
    4. There is a history of EBV infection in the past, and allogeneic hematopoietic stem cell transplantation is required due to other malignant diseases.
  3. No age or gender restrictions;
  4. The subject and the guardian understand and sign the informed consent form.

Exclusion Criteria:

  1. The exclusion criteria for allogeneic hematopoietic stem cell transplantation shall be implemented in accordance with the regulations of the transplant center at the study site;

  2. Exclusion criteria before infusion of JYEST cell injection:

    1. Severe kidney disease (creatinine clearance rate less than 50% of the normal reference value for the same age group);
    2. Severe liver disease (TBil > 2.0×ULN; ALT and AST > 3.0×ULN);
    3. Severe acute infection (opportunistic infection);
    4. Expected survival period less than 6 weeks;
    5. Malnutrition (weight ≤ 10th percentile for the same age group, or serum albumin ≤ 3.0 g/dL);
    6. ECOG score > 2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JYEST Cell Injection Infusion
JYEST cell injection infusion
Biological: JYEST Cell Injection Infusion

A "3+3" dose-escalation design with 3 dose cohorts: 5×10⁷, 1×10⁸, and 2×10⁸ cells.

dosage form: intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence and severity of dose-limiting toxicities (DLT) and adverse reactions
Time Frame: From CAR - T cell infusion to 28 days later
From CAR - T cell infusion to 28 days later

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Epstein-Barr virus (EBV) infection
Time Frame: From CAR - T cell infusion to 2 years later
From CAR - T cell infusion to 2 years later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 28, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

February 27, 2029

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • IIT2026009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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