Supercharged immune cells take on viruses in transplant patients
NCT ID NCT01325636
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested whether giving patients special immune cells (T cells) that target CMV or adenovirus could control these infections after a stem cell transplant. Sixteen children and adults received one or two doses of these cells. The goal was to reduce virus levels in the blood safely. The trial was early-stage, so results are preliminary.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- specific immune cells (CD4 and CD8 T cells) targeting CMV or adenovirus
- What this could lead to
- If it works, this could offer a way to control dangerous viral infections after stem cell transplants without relying on drugs that have side effects.
- What could go wrong
- This was a small, early-phase trial with only 16 patients, so results may not apply broadly. The treatment could also cause graft-versus-host disease or other immune reactions.
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
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
16 people
The number who actually took part.
- Start date
-
Sep 2010
- Finished
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May 2014
- Lead sponsor
-
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
-
Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
-
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: * Child or adult patient (without age limit) treated by allogenic haematopoietic stem cell transplant whatever underlying pathology with a donor chimerism ≥ 10 %, at the time of the inclusion and : * having biological signs (blood viral load) associated or not with clinical signs of infection by CMV and / or resistant or intolerant Adenovirus (myelotoxicity or nephrotoxicity) to a conventional antiviral treatment * or with CMV or ADV disease with organ damage documented without systemic replication (if possible, with a CMV PCR or ADV PCR positive in the organ) * without GvHa at the time of the inclusion or GvHa ≤ II controlled by Corticoids \< 1mg / Kg (but corticosteroids on decrease) or cyclosporine only. A possible treatment by monoclonal antibody anti r-IL2 (LEUCOTAC) must have been interrupted for at least 8 days. The preventive treatment of the GvHa by cyclosporine or mycophenolate mofetil is compatible with the study * answering to eligibility criteria for the donor (in particular donor CMV positive serology and absence of intercurrent infections) * having been informed - he or his legal representative - and having signed the informed consent * patient member or benefiting from a social security scheme Exclusion Criteria: * donor CMV negative serology (in the case of anti-CMV immunotherapy). Note : all donors are considered as having met the adenovirus and the status serology towards this virus, will not be checked. * GvHa \> II and/or requiring a corticosteroid therapy \> 0,5 mg/kg/day and/or a treatment by monoclonal antibody anti-rIl2 could not be interrupted or other immunosuppressor treatment which could potentially interfere with the survival of injected T cell (Thymoglobuline, Campath etc) * severe organ failure involving the patient's vital prognostic in the short term * rejection of sample from the donor
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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.
Contacts and locations
Locations
-
Biotherapy department, Hôpital Necker - Enfants Malades
Paris, 75743, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Banked t cells target four viruses at once in children after transplant
- Can we outsmart Drug-Resistant CMV in transplant patients?
- Can we map CMV's spread in daycares to shield future pregnancies?
- Can immune cells predict herpesvirus danger in transplant patients?
- Can a new IV antiviral tame two stubborn viruses?
- Can specially grown immune cells from donors beat viruses that won't go away?