Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07476014

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria for allogeneic hematopoietic stem cell transplantation shall be implemented in accordance with the regulations of the transplant center at the study site;
  • Patients undergoing allogeneic hematopoietic stem cell transplantation with any of the following high-risk factors for EBV infection:
  • EBV-DNA is positive in the recipient's or donor's serum, whole blood, PBMC or sorted cells before allogeneic hematopoietic stem cell transplantation;
  • 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;
  • 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.;
  • There is a history of EBV infection in the past, and allogeneic hematopoietic stem cell transplantation is required due to other malignant diseases.
  • No age or gender restrictions;
  • The subject and the guardian understand and sign the informed consent form.

Exclusion criteria

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

Treatment and study plan

JYEST Cell Injection Infusion

Biological

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

dosage form: intravenous infusion.

Primary outcomes

  1. The incidence and severity of dose-limiting toxicities (DLT) and adverse reactions

    Time frame: From CAR - T cell infusion to 28 days later

Secondary outcomes

  1. Incidence of Epstein-Barr virus (EBV) infection

    Time frame: From CAR - T cell infusion to 2 years later

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.