An Exploratory Clinical Study of Multivirus-specific T Cells in the Treatment of Refractory Cytomegalovirus and/or Epstein-Barr Virus Infection After Allogeneic Hematopoietic Stem Cell Transplantation

2023PHD006-001

To evaluate the safety and tolerability of partial HLA-matched VSTs against both CMV and EBV viruses in recipients of allogeneic hematopoietic stem cells with refractory viral infections (CMV and/or EBV). Preliminary evaluation of the efficacy of partial HLA-matched VSTs against both CMV and EBV viruses in recipients of allogeneic hematopoietic stem cells with refractory viral infections (CMV and/or EBV); To monitor the duration and expansion of multi-virus VSTs cells after infusion.

2023-11-01

2025-07-30

2025-10-30

Not yet recruiting

Early phase I

29

Inclusion Criteria: * Age ≥18 years old, and less than or equal to 70 years old, gender is not limited. * Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplantation. * Persistent infection with CMV and/or EBV persists despite standard treatment . * Prednisone or its equivalent hormone is less than or equal to 0.5 mg/kg/ day when enrolled. * ECOG score ≤3, expected survival greater than 3 months. * End blood oxygen saturation ≥90% on room air. * Available multi-virus-specific cytotoxic T lymphocytes. * Negative pregnancy test in female patients if applicable. * Written informed consent and/or signed assent line from patient, parent or guardian. Exclusion Criteria: * Within 28 days after allogeneic hematopoietic stem cell transplantation. * Active III-IV acute GVHD, and/or moderate and above chronic GVHD. * Severe organ dysfunction: Heart: New York Heart Association (NYHA) levels III and IV; Liver: Total bilirubin\>34umol/l; ALT, AST\>2 times the normal upper limit; Kidney: Blood creatinine \>130umol/L; Lung: Type I or II respiratory failure; Brain: unconsciousness, intracranial hypertension. * Received DLI, other CTL, CAR-T, NK and other cell therapies, T cell monoclonal antibody immunosuppressants, or participated in any other clinical research related to drugs and medical devices within 28 days before enrollment. * Poor compliance, and subjects deemed unsuitable for study participation by the investigator.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 29, 'type': 'ESTIMATED'}}

2023-10-10