A Phase 2, Multicenter, 3-Cohort Study to Assess the Safety and Efficacy of Using Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients with Metastatic Melanoma.
This is a prospective, single-arm interventional study evaluating autologous tumor infiltrating lymphocyte (TIL) infusion (LN-144) followed by IL-2 after a non-myeloablative chemotherapy preparative regimen for the treatment of metastatic melanoma.
* Patients must have measurable metastatic melanoma and at least one lesion that is resectable for TIL generation. The lesion must be of at least 1.5 cm in diameter and can be surgically removed with minimal morbidity (defined as any operation for which expected hospitalization is less than or equal to three days).
* Patients must have undergone at least one prior systemic treatment for metastatic melanoma.
* Patients must have progressive disease while receiving or after completion of most recent prior treatment.
* Patients must not have received systemic therapy for melanoma for a minimum of two weeks (targeted therapy) and four weeks (all other therapy) prior to the point of enrollment. Prior therapy-related toxicities must have recovered to Grade 1 or less (except for alopecia or vitiligo) according to CTCAE v4.03. Note: Patients may have undergone minor surgical procedures not involving general anesthesia within three weeks prior to enrollment as long as all toxicities have recovered to Grade 1 or less or as specified in the eligibility criteria.
* Patients with documented Grade 2 or greater diarrhea or colitis as a result of previous treatment with ipilimumab, tremelimumab, anti-PD1 or anti-PD-L1 antibodies must have had a normal colonoscopy, including normal biopsy specimens.
Brendan Curti, M.D.
Lion Biotechnologies, Inc.
- Oncology and Hematology Care Eastside