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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Standard of Care medications will be selected by the treating physician for either ADV (Cohort 1) or CMV (cohort 2)
ADV or CMV family matched CTLs will be administered with SOC medications one every 2 weeks as needed up to 5 infusions
Viral PCR to determine resolution of disease
Patients will be monitored weekly by peripheral blood qtPCR values to monitor viral levels for resolution confirmation.
Time frame: Day 100
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