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NCT Number: NCT02007356

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®

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).

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitätsspital Basel

Basel, 4031, Switzerland

Location status: Recruiting

Location contact

Nina Khanna, Dr.

CONTACT

[email protected]

0041-61- ext. 7325

Nina Khanna, Dr.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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:

  • 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
  • Or if antiviral treatment is contraindicated

Patient with EBV:

  • 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:

  • Antiviral treatment with ganciclovir or foscavir for 14 days
  • No Virus load decrease (≤ 1 log) or virus load increase on day 14
  • Or if > 2 recurrences despite antiviral treatment with ganciclovir or foscavir for 14 days and CD3+ cells < 300/µL
  • 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

Treatment and study plan

IFN-γ positive selected T-cells

Biological

Primary outcomes

  1. Level of enriched IFN-γ+ T-cells

    Time frame: 7 days

Secondary outcomes

  1. Treatment efficacy

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Nina Khanna, MD

CONTACT

[email protected]

+41-61-2652525 (Zentrale)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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®

Acronym: CCS

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2013
Registry last updated
Mar 20, 2025

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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