NEW YORK – TCR2 Therapeutics on Monday said it has partnered with Bristol Myers Squibb to study TCR2's autologous cell therapy gavobatagene autoleucel (gavo-cel) together with BMS' checkpoint inhibitors nivolumab (Opdivo) and ipilimumab (Yervoy).
Cambridge, Massachusetts-based TCR2 will sponsor a multi-cohort Phase II trial evaluating various combinations of gavo-cel, nivolumab, and ipilimumab in patients with advanced mesothelin-expressing cancers including non-small cell lung cancer, ovarian cancer, cholangiocarcinoma, and malignant pleural/peritoneal mesothelioma, or MPM. The autologous cell therapy involves harvesting patients' T cells, engineering them into T-cell receptor fusion construct T cells, or TRuC-T cells for short, then reinfusing the engineered cells as a one-time treatment.
TCR2 will evaluate gavo-cel's antitumor activity in the trial at the recommended Phase II dose and better characterize its safety. Patients in the NSCLC, ovarian cancer, and cholangiocarcinoma cohorts will receive gavo-cel and nivolumab, whereas patients in the MPM cohort will receive either single-agent gavo-cel, gavo-cel plus nivolumab, or gavo-cel, nivolumab, and ipilimumab.
The company's decision to launch this trial is informed by early, encouraging data from TCR2's Phase I/II gavo-cel trial, which showed that the autologous cell therapy can shrink various cancers by targeting mesothelin on the cell surface.