Long-term virological response to multiple sequential regimens of highly active antiretroviral therapy for HIV infection.
Gilbert R Kaufmann, Nina Khanna, Rainer Weber...
https://pubmed.ncbi.nlm.nih.gov/15134189Actively Recruiting
Phase 2
Age: 18Years - 65Years
All Genders
ID02007356
Safety and Feasibility Study of Donor-derived Virus-specific T-cell Infusions in Recipients of Hematopoietic Stem Cell Transplantation with Post-transplant Viral Infections Using Cytokine Capture System
Led by University Hospital, Basel, Switzerland · Updated on 2025-03-20
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of infusing donor-derived virus-specific T-cells selected by the cytokine capture system (CCS) in patients who have undergone hematopoietic stem cell transplantation (HSCT) and have treatment-resistant viral infections. This study focuses on infections caused by cytomegalovirus (CMV), Epstein-Barr virus (EBV), and adenovirus. The CCS technology has been used successfully in previous clinical studies in Germany and the UK. The study is conducted as a single-center, open-label, single-arm trial where donor-derived interferon-gamma (IFN-B3) positive T-cells are generated and infused into HSCT recipients with viral infections. Six patients from the University Hospital of Basel will be included. If safety is confirmed, future studies will explore the treatment's efficacy and expand its use to other pathogens and patient groups, including solid organ transplant recipients. Participants will receive the selected IFN-B3 positive T-cell infusions and be closely monitored. Researchers will assess the level of enriched IFN-B3 positive T-cells within 7 days and evaluate treatment efficacy at the same timepoint. Safety and viral response will be regularly checked during the study. The trial started in December 2014 and is expected to continue until December 2026.
CONDITIONS
Brief 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
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults over 18 years of age
- Have undergone allogeneic hematopoietic stem cell transplantation (HSCT)
- Provide written informed consent
- Have treatment-resistant infections with adenovirus, cytomegalovirus (CMV), or Epstein-Barr virus (EBV) meeting specific antiviral treatment response criteria
You will not qualify if you...
- Graft-versus-host disease (GVHD) greater than grade 2 at the time of planned infusion
- Known allergy to iron-dextran or murine antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 7 days
Participants receive donor-derived IFN-γ positive selected T-cell infusions to treat post-transplant viral infections following hematopoietic stem cell transplantation.
1 infusion visit and follow-up assessments over 7 days
Trial Site Locations
Total: 1 location
1
Universitätsspital Basel
Basel, Switzerland, 4031
Actively Recruiting
Loading map...
Research Team
N
Nina Khanna, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here