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

Status

Not yet recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07476014

Enrollment

Registered

2026-03-17

Start date

2026-02-28

Completion date

2029-02-27

Last updated

2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of EBV Infection After Allogeneic Hematopoietic Stem Cell Transplantation

Brief summary

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.

Interventions

BIOLOGICALJYEST 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026