RecruitingPhase 3NCT07225972

Phase 3 Randomized Trial for Refractory ADV or CMV Infection With Family Matched CTLs and Standard of Care (SOC) vs SOC Alone

An Open-Label Prospective Randomized Trial of Family Donor-Derived ADV or CMV CTLs Plus Standard of Care (SOC) vs SOC Alone in Children, Adolescents and Young Adults Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) With Refractory ADV or CMV Infection/Viremia


Sponsor

New York Medical College

Enrollment

138 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with refractory ADV or CMV infection post allogeneic stem cell transplant will be randomized to either Family donor-derived viral specific cytotoxic T lymphocytes (CTLs) plus standard of care (SOC) vs SOC alone.


Eligibility

Min Age: 1 DayMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Standard of Care Antiviral medications and a biological treatment called Viral CTLs for people with adv infection, adv reactivation, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 1 Day to 30 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGStandard of Care Antiviral medications

Standard of Care medications will be selected by the treating physician for either ADV (Cohort 1) or CMV (cohort 2)

BIOLOGICALViral CTLs

ADV or CMV family matched CTLs will be administered with SOC medications one every 2 weeks as needed up to 5 infusions


Locations(2)

New York Medical College

Valhalla, New York, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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NCT07225972


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