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

NCT ID: NCT05471661

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-22

Study Completion Date

2024-05-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Opportunistic Fungal Infection Opportunistic Viral Infection Bone Marrow Transplant Infection

Keywords

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CMV EBV BK virus Adenovirus Aspergillus Fumigatus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients from Hematology Department- Hematopoietic Stem Cell Transplantation Unit, George Papanikolaou Hospital and Bone Marrow Transplantation Unit of the University Hospital of Patras will be eligible to receive penta-STs as treatment for infection of one or more of the target-pathogens or for increasing pathogen load in two consecutive timepoints, following any type of allogeneic transplant.

If patients are receiving steroids for treatment of GVHD or for other reasons, dosage must have been tapered to ≤0.5mg/kg prednisone (or equivalent) prior to study enrollment. Patients may not have received ATG, or Campath or other immunosuppressive monoclonal antibodies in the last 28 days.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Penta-STs

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.

Group Type EXPERIMENTAL

Pentavalent-specific T cells (penta-STs)

Intervention Type 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.

Interventions

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Pentavalent-specific T cells (penta-STs)

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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Received prior myeoloablative or nonmyeloablative allogeneic hematopoietic stem cell transplant.
2. Cells administered as treatment for single or multiple infections/reactivations of one 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 Criteria

1. Received ATG, or Campath or other T cell immunosuppressive monoclonal antibodies in the 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University General Hospital of Patras

OTHER

Sponsor Role collaborator

George Papanicolaou Hospital

OTHER

Sponsor Role lead

Responsible Party

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Evangelia Yannaki

PI, Director of the Gene and Cell Therapy Center, Hematology-HCT Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evangelia Yannaki, MD

Role: PRINCIPAL_INVESTIGATOR

George Papanicolaou Hospital

Locations

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University General Hospital of Patras

Pátrai, , Greece

Site Status

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

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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Penta-STs-001

Identifier Type: -

Identifier Source: org_study_id