Trial record 16 of 47 for:    Open Studies | "Cytomegalovirus Infections"

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® (CCS)

This study is not yet open for participant recruitment.
Verified December 2013 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT02007356
First received: November 26, 2013
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention Phase
Adenovirus Infection
EBV
Cytomegalovirus Infections
Cytokine Capture System®
Allogenic Disease
Biological: IFN-γ positive selected T-cells
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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®

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Level of enriched IFN-γ+ T-cells [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment efficacy [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 6
Study Start Date: April 2014
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: allogeneic HSCT

The present study will evaluate and validate in a single-center, open-label, single arm fashion the safety and feasibility of direct infusions of donor-derived pathogen-specific IFN-γ positive T-cells in recipients of HSCT with post-transplant viral infection according to the previously clinically certified CCS® [3-6]. The Investigator will first generate and apply IFN-γ positive selected T-cells to recipients of HSCT with CMV, EBV or adenovirus as previously published. The Investigator aim is to include 6 patients from the University Hospital of Basel.

With confirmed safety the investigator will in the future perform an efficacy study and extend this treat-ment for other clinically relevant pathogens including human herpesvirus (HHV)-6, HHV-8, polyomaviruses JC and BK and fungi including Aspergillus fumigatus and Candida albicans, to other immunosuppressed patients such as SOT recipients.

Biological: IFN-γ positive selected T-cells

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02007356

Contacts
Contact: Nina Khanna, MD +41-61-2652525 (Zentrale) nina.khanna@usb.ch

Locations
Switzerland
Universitätsspital Basel Not yet recruiting
Basel, Switzerland, 4031
Contact: Nina Khanna, Dr.    0041-61- ext 7325    nina.khanna@usb.ch   
Principal Investigator: Nina Khanna, Dr.         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Nina Khanna, Dr. Universitätsspital Basel,Klinik für Infektiologie und Spitalhygiene, Petersgraben 4, Switzerland 4031
  More Information

Publications:
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02007356     History of Changes
Other Study ID Numbers: EKBB 205/13
Study First Received: November 26, 2013
Last Updated: December 9, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Adenoviridae Infections
Cytomegalovirus Infections
Virus Diseases
DNA Virus Infections
Herpesviridae Infections

ClinicalTrials.gov processed this record on April 16, 2014