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

Last updated: December 24, 2024
Sponsor: George Papanicolaou Hospital
Overall Status: Completed

Phase

1/2

Condition

N/A

Treatment

Pentavalent-specific T cells (penta-STs)

Clinical Study ID

NCT05471661
Penta-STs-001
  • Ages 18-64
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Received prior myeoloablative or nonmyeloablative allogeneic hematopoietic stem celltransplant.

  2. Cells administered as treatment for single or multiple infections/reactivations ofone or more of the following pathogens: AdV, CMV, EBV, ΒΚV and AF.

  3. Karnofsky/Lansky score of ≥ 50.

  4. ANC > 500/μl.

  5. Bilirubin ≤ 2x*, AST < 3x*, Serum creatinine ≤ 2x*, Hemoglobin > 8.0 g/dl.

  6. Pulse oximetry of > 90% on room air.

  7. Available pentavalent-specific T cells.

  8. Negative pregnancy test (if female of childbearing potential)

  9. Patient capable of providing informed consent.

Exclusion

Exclusion Criteria:

  1. Received ATG, or Campath or other T cell immunosuppressive monoclonal antibodies inthe last 28 days.

  2. Steroids > 0.5 mg/kg/day prednisone.

  3. Received donor lymphocyte infusion in last 28 days.

  4. GVHD ≥ grade 2.

  5. Active and uncontrolled relapse of malignancy.

  6. Patients with other uncontrolled infections

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Pentavalent-specific T cells (penta-STs)
Phase: 1/2
Study Start date:
May 22, 2021
Estimated Completion Date:
May 08, 2024

Study 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.

Connect with a study center

  • University General Hospital of Patras

    Patra,
    Greece

    Site Not Available

  • George Papanikolaou Hospital - Gene and Cell Therapy Center- Hematology Dpt- Hematopoietic Stem Cell Transplant Center

    Thessaloníki, 57010
    Greece

    Site Not Available

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