CD45RA-depleted donor cells to help fight stubborn viral infections after haploidentical transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-arm, pragmatic interventional trial using CliniMACS to remove CD45RA-positive naive T cells from donor lymphocytes and infuse the remaining donor memory T cells. The goal is to restore antiviral immunity in patients with persistent or refractory viral infections after haploidentical hematopoietic cell transplantation, while reducing GVHD risk. Participants must have undergone HSCT, have ongoing or recurrent viral infection despite first-line therapy, and have a suitable donor. The study will monitor safety and the ability of the infused cells to control the infections. It is conducted at Ruijin Hospital with collaboration from Shanghai Liquan Hospital.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ruijin Hospital
  Shanghai, Sh, China Recruiting

Study contacts

• Study coordinator: Xiaoxia Hu, MD, PhD
• Email: hu_xiaoxia@126.com
• Phone: 008613795437259

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.