CD45RA-depleted DLI for the Treatment of Refractory/Persistent Viral Infections After Haploidentical Transplantation

Summary

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

Inclusion Criteria:

Participants must meet all of the following criteria:

* 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.
* Adequate organ function, meeting the following laboratory criteria:
* Liver function: ALT and AST ≤ 10 × upper limit of normal (ULN), TBIL ≤ 5 × ULN.
* Renal function: BUN and Cr ≤ 1.25 × ULN.
* No cardiac insufficiency on electrocardiogram (ECG) or echocardiogram.
* Pulmonary function: oxygen saturation \> 90% on room air.
* Willingness and ability of the patient or their legal guardian to receive treatment, comply with the treatment plan, follow-up schedule, and laboratory examinations, and provision of signed informed consent before any study-specific procedure.

Exclusion Criteria:

Patients meeting any of the following criteria will be excluded from this study:

* 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.
* Uncontrolled or relapsed malignancy.
* Presence of other serious acute or chronic physical or psychiatric conditions, or laboratory abnormalities, that may compromise patient safety or compliance, or that may interfere with informed consent, study participation, follow-up, or interpretation of study results.

Conditions3

Interventions1

Related trials

• CD45RA Depleted DLI After TCRα/β Depleted Haploidentical HCT — University Hospital Tuebingen

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