A Pilot Study in the Treatment of Refractory Cytomegalovirus (CMV) Infections With Related Donor CMV Specific Cytotoxic T-cells (CTLs) in Children, Adolescents and Young Adult Recipients
New York Medical College
Summary
CMV cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults (CAYA) with refractory cytomegalovirus (CMV) infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant. Funding Source: FDA OOPD
Eligibility
- Age range
- 0–79 years
- Sex
- All
- Healthy volunteers
- No
1\. Patients with refractory CMV infection post allogeneic HSCT, with primary immunodeficiencies or post solid organ transplant with either * Increasing or persistent quantitative qRT-PCR DNA copies despite two weeks of appropriate anti-viral therapy AND/OR * Medical intolerance to anti-viral therapies including: * ANC \< 500/mm2 secondary to ganciclovir * 2 renal toxicity with foscarnet And/or * known resistance to ganciclovir and/or foscarnet Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures. Performance Status \> 30% (La…
Interventions
- Drugviral specific cytotoxic t-lymphocytes
CMV specific CTLs will be collected from HLA matched or mismatched donors and manufactured in a GMP facility and administered to patients with refractory CMV infection.
Locations (9)
- Children's Hospital Los AngelesLos Angeles, California
- University of California San FranciscoSan Francisco, California
- Indiana UniversityIndianapolis, Indiana
- Johns HopkinsBaltimore, Maryland
- Washington UniversitySt Louis, Missouri
- New York Medical CollegeValhalla, New York