The Phase I open-label, dose-escalation study will dose up to 16 patients and will determine the maximum tolerated dose (MTD) of Imprime PGG in combination with alemtuzumab and rituximab.
The Phase II study will involve 55 patients, who will receive Imprime PGG at the dose level identified in Phase I of the study.
The Phase II study is designed to evaluate the rate of complete response of patients who are treated with Imprime PGG, alemtuzumab, and rituximab.
The study will also evaluate overall subject response, time to progression, time to next treatment, duration of response, and safety of the therapeutic regimen.
Imprime PGG works by binding to and directing neutrophils, the most abundant type of immune cell in the body, to kill cancer.