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

Обзор

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.

Вмешательства

• Биопрепарат 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.

Первичные конечные точки

• The incidence and severity of dose-limiting toxicities (DLT) and adverse reactions [Срок оценки: From CAR - T cell infusion to 28 days later]

Вторичные конечные точки (1)

• Incidence of Epstein-Barr virus (EBV) infection [Срок оценки: From CAR - T cell infusion to 2 years later]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07476014 · IIT2026009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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