Status:
UNKNOWN
Multivirus-specific T Cells in the Treatment of Refractory CMV and/or EBV Infection After Allo-HSCT
Lead Sponsor:
Peking University People's Hospital
Conditions:
CMV Infection
EBV Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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 E...
Detailed Description
This study consists of two parts: (1) The first stage is the safety evaluation of multi-virus VSTs and the exploration of DLT and MTD; (2) The second phase is to evaluate the safety and efficacy of mu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT06075927
Start Date
November 1 2023
End Date
October 30 2025
Last Update
October 10 2023
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