None listed
Conditions
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pediatric, adolescent, or young adult patients (aged =1 to =25 years at the time of transplantation) who have undergone allogeneic hematopoietic stem cell transplantation and have CMV, EBV, or BKV viral infections or related diseases that are resistant or refractory to standard treatment. 2. Patients with evidence of neutrophil engraftment, defined as an absolute neutrophil count (ANC) =0.5 × 10³/µL maintained for 3 consecutive days after allogeneic hematopoietic stem cell transplantation. 3. Patients who are at least Day +21 post-allogeneic hematopoietic stem cell transplantation at the time of screening. 4. Patients with confirmed complete donor chimerism (PCR-short tandem repeats =95%) at the time of first administration. 5. Patients in a clinical condition allowing steroid tapering to =0.5 mg/kg/day of prednisolone (or equivalent dose). 6. Patients who voluntarily decide to participate in this clinical study and provide written informed consent, agreeing to comply with study requirements. 7. Patients deemed eligible for participation based on screening assessments (e.g., vital signs, physical examination, medical and surgical history, ECG, and laboratory tests).
Exclusion criteria
Exclusion criteria: 1. Receipt of ATG (Antithymocyte Globulin), Campath (Alemtuzumab), or other T cell immunosuppressive monoclonal antibody treatment within 28 days prior to the first administration. 2. Presence of uncontrolled organ failure or other uncontrolled bacterial or fungal infections, including: - Moderate to severe hepatic impairment [Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 5× upper limit of normal (ULN)] - Chronic kidney disease [estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m²] 3. Receipt of allogeneic hematopoietic stem cell transplantation or donor lymphocyte infusion (DLI) within 28 days prior to the first administration. 4. Presence of active acute graft-versus-host disease (GvHD) of grade =2. 5. Presence of active malignancy or uncontrolled relapse. 6. Patients deemed unsuitable for participation in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment variables (adverse events, vital signs, physical examination, electrocardiogram, laboratory tests);Change in viral load at each time point after administration of the investigational product;Rate of clinical symptom improvement at each time point after administration of the investigational product | — |
Secondary
| Measure | Time frame |
|---|---|
| Multi-virus specific T cell response at each time point after administration of the investigational product compared to baseline;Cytokine profiling at each time point after administration of the investigational product compared to baseline;Immune cell subset analysis at each time point after administration of the investigational product compared to baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactJae Won Yoo
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed