Study of Autologous Tumour Infiltrating Lymphocytes in Patients With Solid Tumours

Official Title

A Phase 2, Multicentre Study of Autologous Tumour Infiltrating Lymphocytes (LN 144/LN-145/LN-145-S1) in Patients With Solid Tumours

Summary:

A prospective, open-label, multi-cohort, non-randomized, multicentre Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with checkpoint inhibitors or TIL LN-144 (Lifileucel)/LN-145/LN-145-S1 as a single agent therapy.

Trial Description

Primary Outcome:

• Objective Response Rate
• Safety Profile Measured by Grade ≥3 TEAEs

Secondary Outcome:

• Complete Response Rate
• Duration of Response
• Disease Control Rate
• Progression-Free Survival
• Overall Survival

LN-144 (Lifileucel)/LN-145/LN-145-S1 is an adoptive cell transfer therapy that utilizes an autologous TIL for the treatment of patients with unresectable or metastatic melanoma, advanced, recurrent, or metastatic squamous cell carcinoma of the head and neck, and locally advanced or metastatic non-small cell lung cancer. The adoptive cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphodepletion regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2. Patients in Cohorts 1A, 2A, 3A and 3C will receive TIL plus checkpoint inhibitors. Patients in Cohorts 1B, 1C, and 3B will receive autologous TIL as a single therapy.

View this trial on ClinicalTrials.gov