CD45RA-depleted DLI for the Treatment of Refractory/Persistent Viral Infections After Haploidentical Transplantation
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorRuijin Hospital
About this trial
The goal of this clinical trial is to learn whether giving patients special donor immune cells (called "CD45RA Depleted DLI") can help treat viral infections that have not improved with standard antiviral drugs. These infections occur after a stem cell transplant. The study will also look at the safety of this treatment.
Eligibility criteria
Qualifiers
Patients who have undergone hematopoietic stem cell transplantation.
Presence of viremia and/or viral infection-related disease caused by a single virus or multiple viruses among the following: CMV, EBV, ADV, BK, B19, JC, HHV-6B, HSV1, or HSV2.
Patients who, after ≥2 weeks of first-line therapy, have persistent viral positivity, no relief or worsening of clinical symptoms, or re-infection with the same pathogen after viral clearance.
Availability of a suitable lymphocyte donor.
Disqualifiers
Active grade II-IV acute graft-versus-host disease (aGVHD).
Prednisone or equivalent corticosteroid dose > 0.5 mg/kg/day.
Receipt of anti-thymocyte globulin (ATG), alemtuzumab (Campath), or other T-cell immunosuppressive monoclonal antibodies within 28 days before enrollment.
Less than 28 days after allogeneic transplantation, or receipt of donor lymphocyte infusion (DLI) or virus-specific T cell (VST) therapy within 28 days before enrollment.
Trial design
Treatments tested in this trial
- CD45RA depleted donor lymphocyte infusion (DLI)
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Ruijin Hospital
Lead sponsor
Shanghai Liquan Hospital
Collaborator
Source ClinicalTrials.gov