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®

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02007356

Acronym

CCS

Enrollment

Registered

2013-12-10

Start date

2014-12-31

Completion date

2026-12-31

Last updated

2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenovirus Infection, Allogenic Disease, Cytokine Capture System, Cytomegalovirus Infections, EBV

Brief 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).

Interventions

BIOLOGICALIFN-γ positive selected T-cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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: 1\. After receipt of at least one anti-cluster of differentiation 20 antigen (CD20)-antibody treat-ment (375 mg/m2) * No Virus load decrease (≤ 1 log) or virus load increase 7 days after receipt of treatment or * CD3+ cells \< 300/µL 7 days after receipt of treatment or * Clinical progression Patient with CMV: 1. Antiviral treatment with ganciclovir or foscavir for 14 days \- No Virus load decrease (≤ 1 log) or virus load increase on day 14 2. Or if \> 2 recurrences despite antiviral treatment with ganciclovir or foscavir for 14 days and CD3+ cells \< 300/µL 3. Or if antiviral treatment is contraindicated - Patient

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Level of enriched IFN-γ+ T-cells	7 days

Secondary

Measure	Time frame	Description
Treatment efficacy	7 days	Treatment efficacy defined as reduction of virus load, in vivo expansion of antigen-specific T cells in peripheral blood as well as reduction of clinical signs of specific viral infection

Countries

Switzerland

Contacts

Primary ContactNina Khanna, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026