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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- New York Medical College
- Enrollment
- 20
- Locations
- 10
- Primary Endpoint
- Incidence of Response to Treatment (Efficacy)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Month to 79 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
patients with adenoviral infection
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.
Intervention: cytotoxic t-lymphocytes (Drug)
Outcomes
Primary Outcomes
Incidence of Response to Treatment (Efficacy)
Time Frame: 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]
Time Frame: 12 weeks after each infusion
Patients will be followed for adverse events following each infusion of ADV CTLs
Secondary Outcomes
No secondary outcomes reported
Investigators
Mitchell Cairo
Principal Investigator
New York Medical College