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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
cytotoxic t-lymphocytes
Drugadenovirus 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: patients with adenoviral infectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Patients will be followed for adverse events following each infusion of ADV CTLs
Time frame
12 weeks after each infusion2
Incidence of Response to Treatment (Efficacy)
Patients will be followed for improvement in viral infection by monitoring ADV PCR weekly for response to treatment with CTLs
Time frame
12 weeks after last infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
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