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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
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
Assessment of safety and toxicity outcomes in subjects receiving VSTs infusion
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, and graft-versus-host-disease will be summarized using descriptive statistics for each dose level
Time frame: within 56 days after the first VSTs infusion
Assessment of antiviral efficacy of VSTs infusion
Antiviral efficacy including clinical signs of viral infections, virus reinfection, and laboratory measurement of viral load after VSTs infusion will be determined
Time frame: within 56 days after the first VSTs infusion
Virus-specific immune reconstitution
Laboratory measurement of virus-specific immune reconstitution before and after VSTs infusion will be tested
Time frame: within 56 days after the first VSTs infusion
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