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Phase 3 Randomized Trial for Refractory ADV or CMV Infection With Family Matched CTLs and Standard of Care (SOC) vs SOC Alone
Sponsor: New York Medical College
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.
Official title: 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
Key Details
Gender
All
Age Range
1 Day - 30 Years
Study Type
INTERVENTIONAL
Enrollment
69
Start Date
2026-12-01
Completion Date
2032-12-01
Last Updated
2025-11-10
Healthy Volunteers
No
Interventions
Standard of Care Antiviral medications
Standard of Care medications will be selected by the treating physician for either ADV (Cohort 1) or CMV (cohort 2)
Viral CTLs
ADV or CMV family matched CTLs will be administered with SOC medications one every 2 weeks as needed up to 5 infusions