While cellular therapies have achieved remarkable outcomes in the treatment of hematological malignancies, until recently their potential against solid tumors appeared to be limited, due largely to the protective barrier of the tumor microenvironment. But new strategies have been developed to breach that barrier. Roswell Park Comprehensive Cancer Center is moving the science forward by offering clinical trials aimed at extending the benefits of those therapies to patients with all types of solid tumors.
One of the latest studies of this kind — a phase 1 clinical trial for patients with any advanced or metastatic tumor — is gauging the effectiveness of a genetically modified oncolytic virus, CF33-CD19 (brand name OnCARlytics), in combination with blinatumomab (brand name Blincyto), a bispecific T-cell engager (BiTE). Investigators believe this trial, dubbed OASIS, could mark a breakthrough in the treatment of solid tumors.
Christos Fountzilas, MD, FACP, Associate Professor of Oncology, Co-Leader of the Gastrointestinal Clinical Disease Team and Associate Director for Solid Tumors, Early Phase Clinical Trials Program at Roswell Park, serves as Site Principal Investigator. “This study is testing a very innovative platform that can expand the application of cellular immunotherapies to many patients who have cancers that cannot be targeted with more traditional therapies,” he says.
Preclinical studies have demonstrated that CF33-CD19 replicates selectively in tumor cells and marks them for destruction by causing them to express a tumor-associated, non-signaling CD19 protein on their surface that makes them “visible” to therapies targeting CD19.
Blinatumomab, the second agent in the investigational therapy, binds those CD19-positive cancer cells to the CD3-positive T lymphocytes that will destroy them.
The potential of this approach is based on the results of preclinical studies that documented increased recruitment of T cells to the tumor microenvironment and subsequent suppression of tumor growth in mouse models treated with the dual therapy.
Investigators will focus primarily on the safety and tolerability of delivering CF33-CD19 intratumorally or intravenously, alone or in combination with blinatumomab.
Sponsored by Imugene Limited, the clinical trial aims to enroll 36-66 patients at approximately 10 centers across the nation; Roswell Park is the only one in New York State.
BROADCASTMED