UnknownPhase 1

Adoptive T-cell Therapy for Resistant Viral Infections After Allogeneic HSCT

10 participantsStarted 2024-02-27

Plain-language summary

The aim of the study is to evaluate the adverse events and the efficacy of virus specific T lymphocytes selected in vitro from a family donor to treat some refractory viral infections as Adenovirus (ADV), Ebstein Barr virus (EBV), Cytomegalovirus (CMV) that developed in young patients (age between 0 and 21 years) after allogeneic hematopoietic cell transplantation (allo-HSCT) performed at the Transplant Clinical Unit of the IRCCS G. Gaslini Institute (IGG).

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Allogeneic transplant with any cells source and conditioning regimen * Age between 0-21 years * Viral infection/reactivation (CMV, EBV, ADV) * Resistance of viral infections to treatments * Absence of concomitant severe uncontrolled infections * Life expectancy exceeding 30 days * Absence of acute or chronic uncontrolled Graft versus Host Disease (GvHD) * Absence of acute kidney damage (creatinine value\> 3 times the value normal with respect to age) not related to viral infection; * Absence of severe acute liver injury (direct bilirubin\> 3mg / dl or glutamic-oxaloacetic transaminase -SGOT\> 500 UI/L) not related to viral infection; * Presence of informed consent to the treatment of the patient / parent /legal guardian. Exclusion Criteria: * Absence of a suitable donor (seronegativity for the virus in question and / or failure to respond to the secretion test) * Patient with severe renal and/or hepatic impairment as specified above * Primary or secondary graft failure * Relapse of malignant underlying disease

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse events

Timeframe: from day +1 of infusion until day +56

Trial details

NCT IDNCT05075837

SponsorIstituto Giannina Gaslini

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-25

Contact for this trial

Maura Faraci, MD

01056362405 maurafaraci@gaslini.org

View on ClinicalTrials.gov More Viral Infection After HSCT trials