Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07438067
Eligibility Criteria:
Inclusion Criteria:
1. The patient must be aged 18-75 years.
2. ust have undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT).
3. Must have EBV-DNA viremia post-transplant, with EBV-DNA \> 1000 copies/mL (on two consecutive tests or one test \> 10,000 copies/mL).
4. Karnofsky Performance Score (KPS) of 70 or higher.
5. Expected survival of at least 3 months.
6. Sufficient organ function, including renal (serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min), hepatic (AST, ALT, and total bilirubin ≤ 5 × ULN), and hematologic parameters (platelets ≥ 10 × 10\^9/L, neutrophils ≥ 1.0 × 10\^9/L).
7. HLA-matching criteria must be met for the donor/recipient.
Exclusion Criteria:
1. Active GVHD (Grade 2 or higher) or requiring \>0.5 mg/kg/day corticosteroids for GVHD.
2. History of CMV viremia or disease within the past week.
3. PTLD (Post-Transplant Lymphoproliferative Disorder) diagnosed or suspected within 1 week before infusion.
4. Severe active infections (excluding EBV and CMV).
5. Serious allergic reactions or contraindications to the infusion.
6. Previous immune therapy-related adverse events of Grade 3 or higher.
7. History of HIV, HCV, or HBV infection with an active viral load.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07438067
Study Brief:
Protocol Section:
NCT07438067