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

Institute of Hematology & Blood Diseases Hospital, China

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Prevention of EBV Infection After Allogeneic Hematopoietic Stem Cell Transplantation

Treatments: Biological: JYEST Cell Injection Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT07476014

IIT2026009

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Volunteers: No 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 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

JYEST Cell Injection Infusion

Experimental group

Description:

JYEST cell injection infusion

Treatment:

Biological: JYEST Cell Injection Infusion