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®
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IFN-γ positive selected T-cells.
- Who it may be relevant to
- Registry conditions: Adenovirus Infection, EBV, Cytomegalovirus Infections, Cytokine Capture System. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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®
Overview
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
- Biological IFN-γ positive selected T-cells
Primary outcome measures
- Level of enriched IFN-γ+ T-cells [Time frame: 7 days]
Secondary outcome measures (1)
- Treatment efficacy [Time frame: 7 days]
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:
- 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:
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:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- Universitätsspital Basel — Basel
Publications
- 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. PMID 15134189
Identifiers
NCT: NCT02007356 · EKBB 205/13; me12Khanna