Study Design and Treatment Plan
tumor, mTNBC
TUMOR, METASTATIC MELANOMA
This trial was an open-label, phase I study of RNA-electroporated CAR T cells directed against cMET in adults with cMET-expressing mTNBC and metastatic melanoma (ClinicalTrials.gov: NCT01837602). The primary objective was to determine the safety and feasibility of intravenously administered RNA-electroporated CAR T cells directed against cMET. Secondary objectives were to estimate preliminary activity of the investigational therapy and to assess persistence and trafficking of the CAR T-cell product.Subjects were screened for eligibility prior to undergoing a large-volume leukapheresis for collection of peripheral blood mononuclear cells used for CAR T-cell manufacturing. Screening included IHC assessment of baseline cMET expression in tumor sample semiquantitatively by a laboratory developed test using an Study schema is shown in Study procedures. Participant study procedures including cell collection/manufacturing timeline as well as infusion schedule from eligibility confirmation onward.