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A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System® | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®

A Phase I/II Single-center Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®

NCT02007356•University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

Summary

To assess the feasibility of donor-derived interferon (IFN)-γ positive select-ed virus-specific T-cells using the cytokine capture system® (CCS) and the safety of subsequent infusion in recipients of hematopoietic stem cell transplantation (HSCT) with treatment refractory post-transplant viral infections. The CCS has already been successfully used in clinical studies in Germany and United Kingdom (UK).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults \> 18 years of age
•Undergone allogeneic HSCT
•Written informed consent
•Patients with treatment refractory infections with adenovirus, cytomegalovirus (CMV) or Epstein-Barr virus (EBV) will be included in case of fulfilling following criteria:
•Patient with Adenovirus Infection:
•1. Antiviral treatment with cidofovir for at least 7 days
•* no virus load decrease ( ≤ 1 log) or virus load increase on treatment for at least 7 days or
•* cluster of differentiation 3 (CD3) + cells \< 300/µL on treatment for at least 7 days
•2. Or if antiviral treatment is contraindicated
•Patient with EBV:
+9 more criteria

Exclusion Criteria

•graft-versus-host disease (GVHD) \> grade 2 at the time point of planned infusion
•Known allergy to iron-dextran or murine antibodies

Locations (1)

Universitätsspital Basel

Basel, Switzerland

Key Dates

Start Date

December 1, 2014

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

March 20, 2025

Enrollment

ESTIMATED participants

Conditions

Adenovirus InfectionEBVCytomegalovirus InfectionsCytokine Capture SystemAllogenic Disease

Interventions

IFN-γ positive selected T-cells

BIOLOGICAL

Contacts

Nina Khanna, MD

CONTACT

+41-61-2652525 (Zentrale)nina.khanna@usb.ch

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®

Inclusion Criteria

Exclusion Criteria

A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy

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