The purpose of the study is to determine the feasibility, safety and efficacy of administering rapidly-generated donor-derived pentavalent-specific T cells (Penta-STs) to mediate antiviral and antifungal activity in hematopoietic stem cell transplant (HSCT) recipients with AdV, EBV, CMV, BKV or Aspergillus fumigatus (AF) infection/ reactivation or with active disease.
Reconstitution of anti-viral and antifungal immunity by donor-derived antigen-specific T cells has shown promise in preventing and treating infections with CMV, or/and EBV, or/and AdV or/and BKV, HHV6 or/and AF post-transplant. However, the broader implementation of T cell immunotherapy using conventional protocols is limited and until today it was practically impossible for Greece by the cost, the complexity and the time required for virus-specific T cells (VSTs) production and by the antigenic competition between different antigens, which limits the spectrum of viruses that can be targeted in a single T cell product. In this trial, the investigators will evaluate the feasibility, safety and efficacy of donor-derived Penta-STs infusion to allogeneic HSCT recipients with confirmed AdV, EBV, CMV, BKV and AF infection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Patients will receive penta-STs in a single infusion. If they have a partial response or receive therapy post-infusion which could ablate the infused T cells they are eligible to receive up to 2 additional doses from 28 days after their first dose.
University General Hospital of Patras
Pátrai, Greece
George Papanikolaou Hospital - Gene and Cell Therapy Center- Hematology Dpt- Hematopoietic Stem Cell Transplant Center
Thessaloniki, Greece
Acute GvHD
The safety of cell therapy with penta-STs will be assessed according to acute and chronic GvHD grades III-IV
Time frame: Within 6 weeks post the last dose of penta-STs
Chronic GvHD
The safety of cell therapy with penta-STs will be assessed according to acute and chronic GvHD grades III-IV
Time frame: Within 6 months post the last dose of penta-STs
Infusion-related adverse events
The safety of cell therapy with penta-STs will be assessed according to grades ≥3 infusion-related adverse events
Time frame: Within 30 days of the last dose of penta-STs
Non hematological, adverse events
The safety of cell therapy with penta-STs will be assessed according to grades ≥3 non hematological, adverse events within 30 days of the last penta-ST dose, which are not due to the preexisting infection/comorbidities or the original malignancy
Time frame: Within 30 days of the last dose of penta-STs
Resolution of infection - 1
The efficacy of penta-STs will be determined based on the reduction/elimination of pathogen load in patients with infections
Time frame: 12 weeks post the last dose of penta-STs
Resolution of infection - 2
The efficacy of penta-STs will be determined based on the amelioration/elimination of clinical symptoms in patients with viral disease
Time frame: 12 weeks post the last dose of penta-STs
Antiviral immunity
The efficacy of penta-STs will be determined based on the reconstitution of antiviral immunity (determination of virus-specific T cells)
Time frame: 12 weeks post the last dose of penta-STs
Antifungal immunity
The efficacy of penta-STs will be determined based on reconstitution of antifungal immunity (determination of Aspergillus fumigatus-specific T cells)
Time frame: 12 weeks post the last dose of penta-STs
Viral reactivations or recurrence of AF infection
The efficacy of penta-STs will be determined by the absence of viral reactivations or recurrence of AF infection post penta-STs infusion
Time frame: 6 months post the last dose of penta-STs
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