NEW YORK – The University of Minnesota on Monday announced that it had begun enrolling patients in a Phase II clinical trial evaluating a personalized, CRISPR-edited, T-cell therapy for patients with metastatic gastrointestinal solid tumors.
The clinical trial, which is sponsored by Intima Bioscience in collaboration with University of Minnesota's Masonic Cancer Center, will enroll roughly 20 patients with metastatic GI cancers including colorectal, pancreatic, gallbladder, esophageal, and stomach cancers, among others. After receiving systemic chemotherapy to prepare their bodies to receive the treatment, patients enrolled in the trial will undergo a one-time infusion containing their own immune cells that have been harvested and genetically engineered using CRISPR/Cas9 technology to better recognize and attack tumor cells.
Specifically, CRISPR will be used to edit out the cytokine-induced SH2 (CISH) protein from patients' neoantigen-enhanced tumor-infiltrating lymphocytes. According to the trial's investigators, CISH effectively prevents T cells from recognizing and attacking cancer cells, and the strategy of deleting CISH with CRISPR has shown promise in preclinical and periclinical data.
The manufacturing and production of the autologous, CRISPR-edited therapy will take place at the University of Minnesota's Molecular and Cellular Therapeutics (MCT) facility, and the trial's primary aim will be to determine the safety, maximum tolerated dose, and preliminary efficacy of the personalized treatments. As secondary outcomes, the trial's investigators will assess patients' progression-free survival, overall survival, and toxicity profiles.
"Given the potential importance of this novel cancer checkpoint, coupled with precision CRISPR engineered T-cell therapy, we hope that we can start to recapitulate the success that T-cell therapy and immuno-oncology have had in liquid tumors, to the much larger and significant unmet medical need in solid tumor cancer," University of Minnesota's Emil Lou, the study's principal investigator, said in a statement.