This is a Phase II randomized, double-blind, placebo controlled, multi-site study of
Candin. It is designed to show the efficacy and safety of a 7-dose regimen of Candin over
a two-year period in terms of reducing cancer recurrence rate by comparing the recurrence
rates between the Candin and the placebo arm. The ratio of the number of subjects who
will receive Candin versus placebo will be 3:1. Up to 100 subjects will be screened until
80 subjects are eligible for injection.
Additional locations may be listed on ClinicalTrials.gov for NCT05952934.
Locations matching your search criteria
United States
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU LangoneStatus: Active
Name Not Available
This is a Phase II study to evaluate the efficacy and safety of a therapeutic vaccine
called Candin® (Nielsen Biosciences, San Diego, CA) in adults over a two (2) year period.
Each subject will be receiving a total of 7 injections of Candin (0.5 mL per dose) or
placebo (saline) at a 3:1 ratio in a randomized double-blinded design. Subjects will
receive one injection every 3 weeks until they receive 4 injections. Then, subjects will
receive one injection every 3 months until they receive a total of 7 injections. Subjects
will have 2 more visits approximately 6 months apart after the last injection.
Immunological assessment T-cell repertoire analysis and by fluorescent activated cell
sorter analysis (FACS) will be made at 4 time points (Visits 1, 5, 7, and 8). Stool and
oral wash samples will be collected at the Screening Visit, Visit 5, Visit 7 and Visit 8
for microbiome diversity analysis.
Lead OrganizationUniversity of Arkansas for Medical Sciences
Principal InvestigatorOmar T Atiq
