T Lymphocytes for the Treatment of AdV, CMV, EBV, BKV and Aspergillus Fumigatus Infections After Allogeneic Stem Cell Transplantation (Penta-STs-001)

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    10
  • sponsor
    George Papanicolaou Hospital
Updated on 10 August 2022
Accepts healthy volunteers

Summary

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.

Description

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.

Details
Condition Opportunistic Fungal Infection, Opportunistic Viral Infection, Bone Marrow Transplant Infection
Treatment Pentavalent-specific T cells (penta-STs)
Clinical Study IdentifierNCT05471661
SponsorGeorge Papanicolaou Hospital
Last Modified on10 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Received prior myeoloablative or nonmyeloablative allogeneic hematopoietic stem cell transplant
Cells administered as treatment for single or multiple infections/reactivations of one or more of the following pathogens: AdV, CMV, EBV, ΒΚV and AF
Karnofsky/Lansky score of ≥ 50
ANC > 500/μl
Bilirubin ≤ 2x _, AST < 3x_, Serum creatinine ≤ 2x, Hemoglobin > 8.0 g/dl
Pulse oximetry of > 90% on room air
Available pentavalent-specific T cells
Negative pregnancy test (if female of childbearing potential)
Patient capable of providing informed consent

Exclusion Criteria

Received ATG, or Campath or other T cell immunosuppressive monoclonal antibodies in the last 28 days
Steroids > 0.5 mg/kg/day prednisone
Received donor lymphocyte infusion in last 28 days
GVHD ≥ grade 2
Active and uncontrolled relapse of malignancy
Patients with other uncontrolled infections
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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