Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

Phase 2 Terminated 225 enrolled Iovance Biotherapeutics, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2019-05-07
Primary completion: 2026-02-20
Completion: 2026-02-20

Outcome

Outcome not reported

Stopped: “After reviewing the available safety and efficacy data to date, Iovance concluded that the study reached the required number of events for evaluation of study endpoints.”

Publications

Hensel J, Metts J, Gupta A, Ladle BH, Pilon-Thomas S, Mullinax J. Adoptive Cellular Therapy for Pediatric Solid Tumors: Beyond Chimeric Antigen Receptor-T Cell Therapy. Cancer J. 2022 Jul-Aug 01;28(4):322-327. doi: 10.1097/PPO.0000000000000603.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	—	—
Subject	LN-145-S1	Cell therapy	—	—
Subject	Nivolumab	Monoclonal antibody	—	—
Subject	Nivolumab-relatlimab	Monoclonal antibody	—	—
Subject	Pembrolizumab	Monoclonal antibody	—	—
Subject	Tumor Infiltrating Lymphocytes	Cell therapy	—	—
Background	Carboplatin	Small molecule	—	Intravenous
Background	Cisplatin	Other / unclassified	—	Intravenous
Background	Nab-paclitaxel	Small molecule	—	Intravenous
Background	Paclitaxel	Small molecule	—	Intravenous
Background	Pemetrexed	Small molecule	—	Intravenous