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Immune cell boost may help kids beat Post-Transplant viruses

NCT ID NCT07225972

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study tests whether adding immune cells from a family donor to standard antiviral drugs can help children and young adults clear stubborn adenovirus or cytomegalovirus infections after a stem cell transplant. About 69 participants will be randomly assigned to receive either the immune cells plus standard care or standard care alone. The goal is to see if the added cells help the body fight the virus better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Family donor-derived viral-specific cytotoxic T lymphocytes (CTLs) plus standard antiviral medications
What this could lead to
If it works, this could offer a new way to treat hard-to-clear viral infections after stem cell transplant, potentially reducing serious complications.
What could go wrong
This is a small early-stage trial (69 participants) and the added immune cells may not work for everyone or could cause side effects like graft-versus-host disease.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 138 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2026

Expected to finish

Dec 2032

An estimate. End dates often move.

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

1 day to 30 years

Sex

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Patient Eligibility Cohort 1 (ADV) -Patients with ADV viremia (Cohort 1) post AlloHSCT with one or more of the following: Increasing or persistent ADV RT-PCR DNA (\> 1000 ADV PCR copies) after 7 days of appropriate anti-viral therapy AND/OR Medical intolerance to anti-viral therapies including one or more of the following: \> grade 2 renal insufficiency secondary to cidofovir and/or other \> grade 2 toxicities secondary to cidofovir AND/OR Known resistance to cidofovir Patient Eligibility (Cohort 2) (CMV) -Patients with CMV viremia with one or more of the following: Increasing or persistent CMV RT-PCR DNA (\>1000 copies) after 7 days of appropriate anti-viral therapy AND/OR Medical intolerance to anti-CMV antibiotic therapies: ANC \< 500/mm3 secondary to ganciclovir AND/OR \> grade 2 renal toxicity secondary to either foscarnet or cidofovir AND/OR Known resistance to ganciclovir and/or foscarnet * Consent: written informed consent given (by patient or legal representative) prior to any study related procedures * Performance Status \>30% (Lansky \< 16 yrs and Karnofsky \> 16 years (BOTH COHORTS) * Age: 0.01 to 30.00 years (BOTH COHORTS) * Females of childbearing potential with a negative urine pregnancy test at study entry only (BOTH COHORTS) * Family related donor (\> 3 HLA match) that screens positive for ADV5 MACS Peptivator (Cohort 1) or PP65CMV MACS Peptivator (Cohort 2) Donor Eligibility * Related donor available with a T-cell response to the ADV MACS PepTivators (Cohort 1) or CMV MACS PepTivator (Cohort 2). As defined in Appendix II, B, 8.2, the donor is considered suitable if the percentage of IFN+ T-cells is \>0.01% after stimulation with ADV PepTivators (Cohort 1) or CMV PepTivators (Cohort 2). * Third-party related allogeneic donor: If original donor is not available or does not have a T-cell response to ADV MCAS PepTivator (Cohort 1) or CMV PepTivator (Cohort 2), third party allogeneic donor (family donor \> 3 HLA A, B, DR match to recipient) with a T-cell response at least to the ADV MCAS PepTivator (Cohort 1) or CMV PepTivator (Cohort 2) AND * Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1) AND * Obtained informed consents by donor or donor legally authorized representative prior to donor collection Patient Exclusion Criteria (Both Cohorts) * Patient with acute GVHD \> grade 2 or moderate or extensive chronic GVHD at the time of CTL infusion. * Patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of CTL infusion. * Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to CTL infusion. * Patient with poor performance status determined by Karnofksy (patients \> 16 yrs) or Lansky (patients \< 16 years) score \< 30%. * Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory ADV or CMV infections. * Any known medical condition which cold compromise participation in the study according to investigators assessment. * Known AIDS or uncontrolled HIV infection * Known hypersensitivity to iron dextran * Encephalitis and/or retinitis

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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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Medical College of Wisconsin

    NOT_YET_RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • New York Medical College

    RECRUITING

    Valhalla, New York, 10595, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.