NCT07225972

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: New York Medical College · Academic / Other
• Sex: All
• Age: 1 Day – 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

We hypothesize that Family donor-derived viral specific cytotoxic T lymphocytes (CTLs) manufactured by direct selection utilizing the CliniMACS Prodigy® and Cytokine Capture System® plus standard of care (SOC) vs SOC alone in children, adolescents and young adults (CAYA) following allogeneic hematopoietic stem cell transplantation (HSCT) with medically refractory viral infection/viremia and/or intolerant or resistant to anti-viral antibiotic therapy will be associated with a significantly improved probability of Day +100 (time of onset on study) viral progression free survival (VPFS).

Conditions

• CMV
• AdV Infection
• AdV Reactivation
• Adenovirus
• Cytomegalovirus Infections

Interventions

Type	Name	Description
DRUG	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)
BIOLOGICAL	Viral CTLs	ADV or CMV family matched CTLs will be administered with SOC medications one every 2 weeks as needed up to 5 infusions

Timeline

• Start date: 2026-12-01
• Primary completion: 2031-12-01
• Completion: 2032-12-01
• First posted: 2025-11-10
• Last updated: 2025-11-10

Regulatory

• FDA-regulated drug study