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®

Recruiting now · Phase 2

Conditions studied: Adenovirus Infection, EBV, Cytomegalovirus Infections, Cytokine Capture System, Allogenic Disease

In brief

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).

Key facts

Study ID: NCT02007356
Run by: University Hospital, Basel, Switzerland
People needed: 30
Starts: 2014-12-01
Expected to finish: 2026-12-01
Last updated by the study team: 2025-03-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 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:
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

Where it is running

Universitätsspital Basel — Basel, Switzerland (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.