Date: 2016-03-23
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Argos Therapeutics (USA - NC)
Product: AGS-003
Action
mechanism: cell therapy/immunotherapy product. AGS-003 is an autologous dendritic-cell based immunotherapy designed to induce a memory T-cell response specific to a patient's tumor antigens. It is produced using a small sample of RNA from a patient's own tumor and dendritic cells derived from a leukapheresis procedure. In an open-label phase 2 study, treatment with AGS-003 plus sunitinib yielded a median overall survival of more than 30 months in newly diagnosed, unfavorable (intermediate and poor) risk mRCC patients.
Disease: non-small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The research team at CRNN will evaluate the impact of AGS-003 on the toxicity of standard chemotherapy as the primary safety endpoint. Researchers will also measure the activation of memory T-cells in patients who complete the Induction Phase and receive five or more doses of AGS-003 to determine the immunologic response. (NCT02662634)
Latest
news: * On March 23, 2016, Argos Therapeutics announced the initiation of an investigator-sponsored Phase 2 clinical trial of AGS-003 in combination with standard platinum-doublet chemotherapy with or without radiation in patients with newly diagnosed Stage 3 non-small cell lung cancer (NSCLC). The study is being conducted at the Cancer Research Network of Nebraska (CRNN) and is expected to enroll 20 patients. AGS-003 will be administered either concurrently with chemotherapy and with or without radiation or sequentially with chemotherapy and with or without radiation, according to the subject's assigned treatment arm.
