Infusing donor-derived virus-specific T-cells to treat post-transplant viral infections
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®
This study is testing if infusing special immune cells from donors can help patients who have had a stem cell transplant and are struggling with tough viral infections.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT02007356 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of infusing donor-derived, interferon-γ positive selected virus-specific T-cells into patients who have undergone hematopoietic stem cell transplantation and are experiencing treatment refractory viral infections. The approach utilizes the cytokine capture system to select the appropriate T-cells for infusion. The study aims to determine if this method can effectively combat infections caused by adenovirus, cytomegalovirus, and Epstein-Barr virus in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have undergone allogeneic hematopoietic stem cell transplantation and have refractory infections from adenovirus, cytomegalovirus, or Epstein-Barr virus.
Not a fit: Patients who do not have treatment refractory viral infections or those who have not undergone allogeneic hematopoietic stem cell transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from persistent viral infections after stem cell transplantation.
How similar studies have performed: Previous studies in Germany and the UK have successfully utilized the cytokine capture system for similar approaches.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basel
- Universitätsspital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Nina Khanna, Dr. — Universitätsspital Basel, Klinik für Infektiologie
- Study coordinator: Nina Khanna, MD
- Email: nina.khanna@usb.ch
- Phone: +41-61-2652525 (Zentrale)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.