Clinical trial 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®
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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Adenovirus Infection
EBV
Cytomegalovirus Infections
Cytokine Capture System
Allogenic Disease
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2013-12-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Level of enriched IFN-γ+ T-cells
timeFrame: 7 days
Secondary outcomes:
measure: Treatment efficacy
timeFrame: 7 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitätsspital Basel
Study officials:
affiliation: Universitätsspital Basel, Klinik für Infektiologie
name: Nina Khanna, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaufmann GR, Khanna N, Weber R, Perrin L, Furrer H, Cavassini M, Ledergerber B, Vernazza P, Bernasconi E, Rickenbach M, Hirschel B, Battegay M; Swiss HIV Cohort Study. Long-term virological response to multiple sequential regimens of highly active antiretroviral therapy for HIV infection. Antivir Ther. 2004 Apr;9(2):263-74.