Actively Recruiting
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®
Led by University Hospital, Basel, Switzerland · Updated on 2025-03-20
30
Participants Needed
1
Research Sites
626 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
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®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years of age
- Have undergone allogeneic hematopoietic stem cell transplantation
- Provide written informed consent
- Have treatment-refractory infections with adenovirus, cytomegalovirus (CMV), or Epstein-Barr virus (EBV) defined as follows:
- For adenovirus: antiviral treatment with cidofovir for at least 7 days without virus load decrease (≤ 1 log) or virus load increase, or CD3+ cells less than 300/µL during treatment, or if antiviral treatment is contraindicated
- For EBV: after at least one anti-CD20 antibody treatment (375 mg/m2) with no virus load decrease (≤ 1 log) or virus load increase 7 days post-treatment, or CD3+ cells less than 300/µL 7 days post-treatment, or clinical progression
- For CMV: antiviral treatment with ganciclovir or foscavir for 14 days without virus load decrease (≤ 1 log) on day 14, or more than 2 recurrences despite antiviral treatment and CD3+ cells less than 300/µL, or if antiviral treatment is contraindicated
You will not qualify if you...
- Graft-versus-host disease (GVHD) greater than grade 2 at the planned infusion time
- Known allergy to iron-dextran or murine antibodies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Universitätsspital Basel
Basel, Switzerland, 4031
Actively Recruiting
Research Team
N
Nina Khanna, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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