Phase I clinical trial to determine the Phase II dose of autologous TIL 1383I TCR gene modified T Cells using a retrovirus. This is a novel National Cancer Institute (NCI) funded investigator initiated therapy for patients with advanced melanoma.
Name: Escalating Doses
Description: Subjects will receive a single infusion of autologous bulk TIL 13831 TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 13831 TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4 + and CD8+ T Cells expressing the TIL 13831 TCR. Subjects in Cohort 1 will receive 7.5 x 10^6/kg TIL 1383I TCR transduced T cells. Subjects in Cohort 2 will receive 2.5 x 10^7/kg TIL 1383I TCR transduced T cells. Subjects in Cohort 3 will receive 7.5 x 10^7/kg TIL 1383I TCR transduced T cells.Type: BiologicalEscalating Doses
Description: Establish a recommended phase II dose of autologous T cell receptor transduced T cells by evaluating unexpected Grade 2 adverse events through Grade 5 regardless of attribution, all toxicities attributed to the cells, and all incidences of intubation including the duration and reason for intubation.
Measure: Approximately 18 patients with Grade 2 through Grade 5 Adverse Events that are related to study drug, graded according to NCI CTCAE Version 4.0 Time: 4 weeksDescription: Change in T cell count from baseline to 4 weeks.
Measure: Immunologic changes in T cell count Time: Baseline and 4 weeksDescription: Potential auditory changes from baseline to 4 weeks.
Measure: Audiologic changes of Grade 2 or higher as related to study drug, graded according to NCI CTCAE Version 4.0 Time: Baseline and 4 weeksDescription: Potential visual changes from baseline to 4 weeks.
Measure: Ophthalmologic changes or development of Uveitis of Grade 2 or higher as related to study drug, graded according to NCI CTCAE Version 4.0 Time: Baseline and 4 weeksDescription: CT scan or physical examination will be used to evaluate for a clinical objective response in patients who have received transduced T Cells at scheduled time points.
Measure: CT scans or physical examination from approximately 18 patients will be used to evaluate for a clinical objective response using RECIST Guideline Version 1.1 Time: Baseline and 4 weeksSingle Group Assignment
There is one SNP
- Patients with V600E mutations are eligible if they have failed an approved BRAF inhibitor or MEK inhibitor therapy or have refused treatment with an approved BRAF inhibitor or MEK inhibitor. --- V600E ---