Loyola University
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.
This is a Phase 1 dose escalation study designed to find the highest dose of TIL 1383I TCR transduced T cells that can safely be given. Three cohorts of 3 patients will be treated with increasing doses of TIL 1383I TCR transduced T cells. Patients will be monitored clinically and immunologically for a year after infusion. 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.
Inclusion Criteria: * Patients must have a diagnosis of metastatic melanoma which is evaluable either clinically or radiologically. * Patients must be 18 years of age or older. * Patients must consent to be in the study and must have signed and dated an approved consent form, which conforms to federal and institutional guidelines. * Patients must have a performance status (PS) of 0 or 1 ECOG PS scale. * Patients must have the ability to provide written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the stud…
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.
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