A Phase lb Clinical Trial of Oncoquest™-CLL Vaccine for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia (IND 15639). The trial is designed to determine the safety and clinical outcome of patients vaccinated with Oncoquest™-CLL. In these patients, the immune system has not yet been compromised by the disease and/or other treatments. The patients are still in an early asymptomatic stage when a ‘watchful waiting’ approach is used before initiation of standard therapy.
Potentially eligible patients are identified by their treating physician in the Hematology/Oncology outpatient clinic of Northwestern Medical Faculty Foundation. After informed consent and registration, patients undergo a single course of leukapheresis to collect peripheral blood mononuclear cells (PBMC), which are be shipped to XEME for autologous Oncoquest™-CLL vaccine manufacturing. Patients are receiving a total of 5 sequential doses of Oncoquest™-CLL vaccine via subcutaneous injection. The treatment period (including leukapheresis vaccine manufacturing and vaccine administration) is approximately 4-5 months.
Protocol No.: NU 13H05 (X12-11008)
Shuo Ma, M.D., Ph.D.
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
303 E. Superior Street, Suite 3-125
Chicago, IL 60611
Status: Active, not recruiting
Clinical Trial Information: https://clinicaltrials.gov/ct2/show/NCT01976520