Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC

Phase 1 Recruiting 20 enrolled H. Lee Moffitt Cancer Center and Research Institute

NaSingle-groupOpen-labelTreatment

Summary

To determine the effect of a special preparation of cells, called tumor-infiltrating lymphocytes (TIL) stimulated with CD40L, when given with the drug nivolumab, for patients with EGFR, ALK, ROS1, or HER2-genomically altered lung cancer.

Timeline

Start: 2023-03-10
Primary completion: 2026-06
Completion: 2027-12

Publications

Results Creelan BC, Wang C, Teer JK, Toloza EM, Yao J, Kim S, Landin AM, Mullinax JE, Saller JJ, Saltos AN, Noyes DR, Montoya LB, Curry W, Pilon-Thomas SA, Chiappori AA, Tanvetyanon T, Kaye FJ, Thompson ZJ, Yoder SJ, Fang B, Koomen JM, Sarnaik AA, Chen DT, Conejo-Garcia JR, Haura EB, Antonia SJ. Tumor-infiltrating lymphocyte treatment for anti-PD-1-resistant metastatic lung cancer: a phase 1 trial. Nat Med. 2021 Aug;27(8):1410-1418. doi: 10.1038/s41591-021-01462-y. Epub 2021 Aug 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tumor Infiltrating Lymphocytes	Cell therapy	—	—
Background	Cyclophosphamide	Other / unclassified	—	—
Background	Fludarabine	Small molecule	—	—
Background	Nivolumab	Monoclonal antibody	480 mg	Intravenous
Background	aldesleukin	Protein / enzyme biologic	—	—

Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC

Summary

Timeline

Publications

Drugs

Indications