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Tests treatment safety and results for Adenovirus Infection
Official title 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®
ClinicalTrials.gov ID: NCT02007356
What this study is testing
What is IFN-γ positive selected T-cells?
IFN-γ positive selected T-cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for adenovirus infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Antiviral treatment with cidofovir for at least 7 days
You likely can't join if
- graft-versus-host disease (GVHD) \> grade 2 at the time point of planned infusion
- Known allergy to iron-dextran or murine antibodies
See the full eligibility 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
- graft-versus-host disease (GVHD) \> grade 2 at the time point of planned infusion
- Known allergy to iron-dextran or murine antibodies
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.