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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® (CCS)

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ClinicalTrials.gov Identifier: NCT02007356
Recruitment Status : Recruiting
First Posted : December 10, 2013
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (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®
Study Start Date : December 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 solid organ transplant (SOT) recipients.

Biological: IFN-γ positive selected T-cells


Outcome Measures

Primary Outcome Measures :
  1. Level of enriched IFN-γ+ T-cells [ Time Frame: 7 days ]

Secondary Outcome Measures :
  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


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007356


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

Locations
Switzerland
Universitätsspital Basel 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
First Posted: December 10, 2013    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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