A Pilot Study in the Treatment of Refractory Adenovirus (ADV) Infection With Related Donor ADV Cytotoxic T-Lymphocytes (ADV-CTLs)in Children, Adolescents and Young Adult Recipients
New York Medical College
Summary
Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with refractory ADV 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 Adenovirus infections post allogeneic HSCT, with primary immunodeficiencies or post solid organ transplant with: * Increasing or persistent quantitative ADV RT-PCR DNA copies despite two weeks of appropriate anti-viral therapy and/or * clinical symptoms attributed to adenovirus, including pneumonitis, hemorrhagic cystitis, colitis, hepatitis AND/OR * Medical intolerance to anti-viral therapies including: * grade 2 renal insufficiency secondary to cidofovir Consent: Written informed consent given (by patient or legal representative) prior to any study-related pr…
Interventions
- Drugcytotoxic t-lymphocytes
adenovirus specific cytotoxic t-lymphocytes will be collected and manufactured from HLA matched related or HLA mis-matched related donors and administered to eligible patients with refractory adenovirus or PID.
Locations (10)
- Children's Hospital Los AngelesLos Angeles, California
- University of California San FranciscoSan Francisco, California
- Children's Hospital of ColoradoAurora, Colorado
- University of Colorado DenverAurora, Colorado
- Indiana UniversityIndianapolis, Indiana
- Johns HopkinsBaltimore, Maryland