Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection
NCT03266627 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-08-08
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
Conditions
- Adenovirus
- Primary Immune Deficiency Disorder
Interventions
- DRUG
-
cytotoxic 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.
Sponsors & Collaborators
-
Children's Hospital of Philadelphia
collaborator OTHER -
Medical College of Wisconsin
collaborator OTHER -
Nationwide Children's Hospital
collaborator OTHER - collaborator OTHER
-
University of California, San Francisco
collaborator OTHER -
University of Colorado, Denver
collaborator OTHER -
Indiana University
collaborator OTHER -
Washington University School of Medicine
collaborator OTHER -
University of California, Los Angeles
collaborator OTHER -
New York Medical College
lead OTHER
Principal Investigators
-
Mitchell Cairo, MD · New York Medical College
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Month
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-01
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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