drugset / Trial / NCT03467516

Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma

NCT03467516

Phase 2 Active not recruiting 34 enrolled Udai Kammula
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 2 study in which the efficacy of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous TIL and high-dose aldesleukin in patients with metastatic uveal melanoma will be evaluated. Metastatic uveal melanoma (UM) carries a poor prognosis with estimated survival of 4-6 months. There are no known effective systemic therapies. Metastatic UM is classified as an "orphan" disease and there are currently few clinical trial options for these patients. Thus, novel systemic approaches are desperately needed. A recent pilot study has found that administration of autologous tumor infiltrating lymphocytes (TIL) generated from resected metastases can induce objective tumor response and durable complete response in metastatic uveal melanoma patients. These encouraging results require confirmation to determine if this immunotherapy is of future benefit in treating this disease.

Timeline

Start
2018-05-14
Primary completion
2027-07-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Tumor Infiltrating Lymphocytes Cell therapy 1e+09 cells Intravenous
Subject Tumor Infiltrating Lymphocytes Cell therapy 2e+11 cells Intravenous
Background aldesleukin Protein / enzyme biologic 600000 iu/kg Intravenous

Indications