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Completed

NCT Number: NCT05471661

T Lymphocytes for the Treatment of AdV, CMV, EBV, BKV and Aspergillus Fumigatus Infections After Allogeneic Stem Cell Transplantation

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.

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Key information

Conditions

Opportunistic Fungal Infection Adenoviridae Infections Bone Marrow Transplant Infection DNA Virus Infections Infections Opportunistic Viral Infection Virus Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University General Hospital of Patras, Pátrai, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pentavalent-specific T cells (penta-STs)

Biological

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.

Primary outcomes

  1. Acute GvHD

    Time frame: Within 6 weeks post the last dose of penta-STs

    The safety of cell therapy with penta-STs will be assessed according to acute and chronic GvHD grades III-IV

  2. Chronic GvHD

    Time frame: Within 6 months post the last dose of penta-STs

    The safety of cell therapy with penta-STs will be assessed according to acute and chronic GvHD grades III-IV

  3. Infusion-related adverse events

    Time frame: Within 30 days of the last dose of penta-STs

    The safety of cell therapy with penta-STs will be assessed according to grades ≥3 infusion-related adverse events

  4. Non hematological, adverse events

    Time frame: Within 30 days of the last dose of penta-STs

    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

  5. Resolution of infection - 1

    Time frame: 12 weeks post the last dose of penta-STs

    The efficacy of penta-STs will be determined based on the reduction/elimination of pathogen load in patients with infections

  6. Resolution of infection - 2

    Time frame: 12 weeks post the last dose of penta-STs

    The efficacy of penta-STs will be determined based on the amelioration/elimination of clinical symptoms in patients with viral disease

  7. Antiviral immunity

    Time frame: 12 weeks post the last dose of penta-STs

    The efficacy of penta-STs will be determined based on the reconstitution of antiviral immunity (determination of virus-specific T cells)

  8. Antifungal immunity

    Time frame: 12 weeks post the last dose of penta-STs

    The efficacy of penta-STs will be determined based on reconstitution of antifungal immunity (determination of Aspergillus fumigatus-specific T cells)

  9. Viral reactivations or recurrence of AF infection

    Time frame: 6 months post the last dose of penta-STs

    The efficacy of penta-STs will be determined by the absence of viral reactivations or recurrence of AF infection post penta-STs infusion

Sponsors and collaborators

Lead sponsor

George Papanicolaou Hospital

Other

Collaborators

  • University General Hospital of Patras

Registry information

Official study title

Administration of Rapidly Generated Multipathogen-specific T-Lymphocytes for the Treatment of AdV, CMV, EBV, BKV and Aspergillus Fumigatus Infections Post Allogeneic Stem Cell Transplant

Acronym: Penta-STs-001

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2022
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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