Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-79
SponsorNew York Medical College
About this trial
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 criteria
Qualifiers
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
grade 2 renal insufficiency secondary to cidofovir Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.
Donor Eligibility Related donor available with a T-cell response to the viral MACS® GMP PepTivator antigen(s) of adenovirus.
Disqualifiers
None
Trial design
Treatments tested in this trial
- cytotoxic t-lymphocytes
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
New York Medical College
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
Medical College of Wisconsin
Collaborator
Nationwide Children's Hospital
Collaborator
Johns Hopkins University
Collaborator
University of California, San Francisco
Collaborator
University of Colorado, Denver
Collaborator
Indiana University
Collaborator
Washington University School of Medicine
Collaborator
University of California, Los Angeles
Collaborator
Source ClinicalTrials.gov