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Trial Title:
Multivirus-specific T Cells in the Treatment of Refractory CMV and/or EBV Infection After Allo-HSCT
NCT ID:
NCT06075927
Condition:
CMV Infection
EBV Infection
Stem Cell Transplant
Conditions: Official terms:
Infections
Communicable Diseases
Cytomegalovirus Infections
Epstein-Barr Virus Infections
Conditions: Keywords:
Cytomegalovirus
Epstein Barr virus
Multivirus-specific Cytotoxic T-Lymphocytes
Stem Cell Transplant
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Virus specific T cells
Description:
Subjects will receive partial HLA-matched viral-specific T cells (VSTs) against both CMV
and EBV on one of the following dose levels:
Level One: 1 x 10^7 cells/m2 Level Two: 2 x 10^7cells/m2 Level Three: 5x 10^7 cellss/m2
Arm group label:
VSTs infusion
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 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.
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 multi-viral VSTs in selecting appropriate doses in the first
phase.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
November 1, 2023
Completion date:
October 30, 2025
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06075927
