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

Not Applicable

Not yet recruiting

• Conditions: CMV; AdV Infection; AdV Reactivation; Adenovirus; Cytomegalovirus Infections
• Interventions: Drug: Standard of Care Antiviral medications; Biological: Viral CTLs

• Registration Number: NCT07225972
• Lead Sponsor: New York Medical College

Brief 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).

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-04
• Study First Submitted QC: 2025-11-06
• Last Update Submitted: 2025-11-06
• Study First Posted: 2025-11-10
• Last Update Posted: 2025-11-10
• Study Start: 2026-12-01
• Primary Completion: 2031-12-01
• Study Completion: 2032-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard of Care Medication	Standard of Care Antiviral medications	Patients will receive standard of care antiviral therapy for CMV or ADV at the discretion of the physician.
Standard of Care Medication plus Cytotoxic T-Lymphocytes (CTLs)	Standard of Care Antiviral medications	Patients will be randomized to receiving standard of care antiviral therapy plus family matched donor derived CTLs.
Standard of Care Medication plus Cytotoxic T-Lymphocytes (CTLs)	Viral CTLs	Patients will be randomized to receiving standard of care antiviral therapy plus family matched donor derived CTLs.

Primary Outcome Measures

Name	Time	Method
Viral PCR to determine resolution of disease	Day 100	Patients will be monitored weekly by peripheral blood qtPCR values to monitor viral levels for resolution confirmation.