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.

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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.

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Protocol No.: NU 13H05 (X12-11008)

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Principal Investigator:

Shuo Ma, M.D., Ph.D.
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
303 E. Superior Street, Suite 3-125
Chicago, IL 60611
312-908-5250 (phone)
312-908-1372 (fax)
Shuo-ma@northwestern.edu

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Status: Active, not recruiting

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Clinical Trial Information: https://clinicaltrials.gov/ct2/show/NCT01976520