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


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 pembrolizumab or TIL LN-145/LN-145-S1 as a single 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 manufacturing process for the treatment of patients with advanced unresectable or metastatic melanoma, advanced squamous cell carcinoma of the head and neck, and 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, Cohort 2A, and Cohort 3A will receive TIL plus pembrolizumab. Patients in Cohorts 1B and Cohort 3B will receive TIL as a single therapy.

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society