Phase 2 Clinical Trial NCT03645928 by Iovance Biopharmaceuticals
Tumor Infiltrating Lymphocytes
https://clinicaltrials.gov/ct2/show/NCT03645928?term=NCT03645928&draw=2&rank=1#contacts
For those ALK+ patients that may be searching for a treatment after TKIs and standard treatments, one interesting option is the clinical trial NCT03645928, the Study of Autologous Tumor Infiltrating Lymphocytes (TIL) in Patients With Solid Tumors, by Iovance Biopharmaceuticals using their product Lifileucel, or LN-145.
Iovance’s technology represents personalized therapy consisting of a one-time treatment of expanding and rejuvenating the patient’s own immune cells to treat the cancer. In the early stages of cancer, the body’s own TIL mobilize and attack the tumors, but the cancer adapts and evades detection, while chemically suppressing the immune response in the local environment. Iovance’s technology is designed to address these obstacles to the natural anti-tumor immune response. A tumor is surgically resected, the TIL are extracted then expanded to billions in number in a tissue culture with Interleukin-2, which eliminates the immune-suppressive environment altogether. The amplified TIL are then reinjected into the patient, hopefully mediating anti-tumor responses with strong durability.
Lifileucel has shown prior safety and efficacy in treating Melanoma in a clinical trial. The solid tumor trial mentioned above, is a Phase 2 trial for patients with melanoma, head and neck cancers, as well as NSCLC including ALK+ patients treated previously with TKIs under certain conditions (see cohorts 3A and 3B). There are 41 worldwide trial locations, with 23 located in the US.
Iovance is a development-stage biotechnology company listed on the NASDAQ stock exchange, and located in San Carlos, CA. They are well-funded, and are currently building a facility for TILs processing in Philadelphia. The technology comes out of research originally developed at the National Institute of Health, and the company has partnerships with Moffitt Center, Yale, and MD Anderson.
Contact information and trial sites can be found here:
https://clinicaltrials.gov/ct2/show/NCT03645928?term=NCT03645928&draw=2&rank=1#contacts
Or, https://www.iovance.com/clinical/immunotherapy-for-solid-tumors/
For questions, please email clinical.inquiries@iovance.com
Or, to speak with someone about the trial, call the Iovance Call Center at 1-866-565-4410, press option 3
More information on Iovance can be found here: