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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JYEST Cell Injection Infusion.
- Who it may be relevant to
- Registry conditions: Prevention of EBV Infection After Allogeneic Hematopoietic Stem Cell Transplantation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- 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.
Primary outcome measures
- The incidence and severity of dose-limiting toxicities (DLT) and adverse reactions [Time frame: From CAR - T cell infusion to 28 days later]
Secondary outcome measures (1)
- Incidence of Epstein-Barr virus (EBV) infection [Time frame: From CAR - T cell infusion to 2 years later]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07476014 · IIT2026009