Last updated: October 4, 2023
Sponsor: Peking University People's Hospital
Overall Status: Active - Not Recruiting
Phase
1/2
Condition
Cytomegalovirus Infections
Stem Cell Transplant
Treatment
Virus specific T cells
Clinical Study ID
NCT06075927
2023PHD006-001
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 celltransplantation.
- 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 whenenrolled.
- 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
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 monoclonalantibody immunosuppressants, or participated in any other clinical research related todrugs and medical devices within 28 days before enrollment.
- Poor compliance, and subjects deemed unsuitable for study participation by theinvestigator.
Study Design
Total Participants: 29
Treatment Group(s): 1
Primary Treatment: Virus specific T cells
Phase: 1/2
Study Start date:
November 01, 2023
Estimated Completion Date:
October 30, 2025