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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CD45RA depleted donor lymphocyte infusion (DLI)
Biological/VaccineCD45RA depleted donor lymphocyte infusion (DLI) admission with escalated dose
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants Achieving Overall Response of Viral Infection Based on Quantitative PCR and Clinical Response Criteria
Overall response rate is defined as the percentage of participants who achieve complete response or partial response after CD45RA-depleted DLI. Complete response is defined as negative viral PCR together with disappearance of all virus-related clinical signs and symptoms. Partial response is defined as at least a 50% reduction in viral load from baseline together with at least 1-grade improvement in clinical symptoms. Overall response rate will be calculated as the number of participants with complete response or partial response divided by the total number of evaluable participants.
Time frame
90 days after the first CD45RA-depleted donor lymphocyte infusionSecondary outcomes
1
Virus-specific T-cell Response
Virus-specific T-cell response will be assessed in peripheral blood using the protocol-specified virus-specific T-cell assay. The assessment may include virus-specific T-cell responses against clinically relevant protocol-specified viruses, including CMV, EBV, adenovirus, BK virus, B19, HHV-6, and JC virus, as applicable to each participant's viral infection. The outcome will summarize the change from baseline in virus-specific T-cell response after CD45RA-depleted DLI.
Time frame
90 days after the first CD45RA-depleted DLI2
Grade III-IV Acute Graft-versus-Host Disease
This outcome will measure the percentage of participants who develop new-onset Grade III-IV acute graft-versus-host disease after CD45RA-depleted DLI. Acute GVHD will be assessed and graded according to MAGIC criteria.
Time frame
90 days after the first CD45RA-depleted DLI3
Chronic Graft-versus-Host Disease
This outcome will measure the percentage of participants who develop chronic graft-versus-host disease after CD45RA-depleted DLI. Chronic GVHD will be assessed and graded according to NIH 2014 criteria, including mild, moderate, and severe chronic GVHD.
Time frame
Up to 1 years after CD45RA-depleted DLISponsors and contacts
Click on the lead sponsor to view all of their trials.
Ruijin Hospital
Lead sponsor
Shanghai Liquan Hospital
Collaborator
Source ClinicalTrials.gov