Can 'Supercharged' donor cells beat viruses that drugs Can't?
NCT ID NCT07662369
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether giving patients special donor immune cells (called CD45RA-depleted DLI) can treat viral infections that persist after a stem cell transplant. The trial involves 30 participants who have not improved with standard antiviral drugs. Researchers will measure how many patients clear the virus or see at least a 50% reduction in viral load.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CD45RA-depleted donor lymphocyte infusion (DLI)
- What this could lead to
- If it works, this could offer a new way to fight viral infections that don't respond to standard drugs after a stem cell transplant.
- What could go wrong
- This is an early phase 1/2 trial with only 30 participants, so results are preliminary. There may be risks like graft-versus-host disease or the treatment not working for all viruses.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ruijin Hospital
RECRUITINGShanghai, SH, 200025, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can regional data improve bone marrow transplant results for blood cancers?
- Could a frailty score predict which older cancer patients survive intensive care?
- Why COVID-19 hits blood cancer patients harder: scientists map the immune clues
- Banked t cells target four viruses at once in children after transplant
- Softer chemo before stem cell transplant aims to cure blood cancers in frail children
- Can a new drug stop the Body's attack after stem cell transplants?