Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection
- Conditions
- AdenovirusPrimary Immune Deficiency Disorder
- Interventions
- Drug: cytotoxic t-lymphocytes
- Registration Number
- NCT03266627
- Lead Sponsor
- New York Medical College
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description patients with adenoviral infection cytotoxic t-lymphocytes patients will receive CTL dose x 1 with 2.5 × 10(4) CD3/kg for matched related donor and 0.5 × 104 CD3/kg for mis-matched related donor. Patients who don't respond to the first infusion may receive up to a total 5 CTL infusions.
- Primary Outcome Measures
Name Time Method Incidence of Response to Treatment (Efficacy) 12 weeks after last infusion Patients will be followed for improvement in viral infection by monitoring ADV PCR weekly for response to treatment with CTLs
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 12 weeks after each infusion Patients will be followed for adverse events following each infusion of ADV CTLs
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
University of California San Francisco
🇺🇸San Francisco, California, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Nationwide Children's Hosptial
🇺🇸Columbus, Ohio, United States
Children's Hospital of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Children's Hospital of Colorado
🇺🇸Aurora, Colorado, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Medical College of Wisconsin/Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Washington University
🇺🇸Saint Louis, Missouri, United States