Investigators plan to analyze if treatment with an experimental, CAR-T cell therapy is safe and effective in a small group of patients with relapsed or refractory metastatic colorectal cancer.
Innovative Cellular Therapeutics announced that the first patient has been treated in an early-phase clinical trial assessing the safety and efficacy of GCC19CART, an investigational single-infusion CAR-T cell therapy, for relapsed or refractory metastatic colorectal cancer.
Colorectal cancer develops in a person’s colon or rectum, which is located at the lower end of the digestive tract. When the disease spreads to other areas of the body, it is then considered to be metastatic. A patient has relapsed or refractory disease when their tumor has stopped responding to prior treatment regimens.
“There is a significant unmet medical need for relapsed/refractory metastatic colorectal cancer patients,” Innovative Cellular Therapeutics CEO Dr. Larry Lei Xiao said in a press release. “We believe that GCC19CART has the potential to provide significant clinical benefit to these patients.”
According to a filing on ClinicalTrials.gov, the multicenter phase 1 trial is expected to enroll 30 adults.
The main goal of the study is to analyze the incidence of side effects defined as dose-limiting toxicities. The investigators also aim to identify a maximum tolerable dose and set a recommended dose for future clinical trials.
Other goals of the study include assessing GCC19CART’s effect on overall response (rate of patients whose disease partially or completely responds to treatment), progression-free survival (defined as time from day 30 to approximately 13 months or earliest date of disease progression) and overall survival.
Enrolled patients must have received prior therapy with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy in the metastatic setting (or palliative therapy within 12 months of adjuvant therapy), an anti-vascular endothelial growth factor (anti-VEGF) biological therapy if not contraindicated, and if RAS wild-type an anti-epidermal growth factor receptor (anti-EGFR) therapy.
Moreover, patients enrolled on to the study must have limited liver disease and have no surgical treatment option that has a curative intent.
Patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient tumors are excluded from enrolling into the trial.
The safety portion of the trial is expected to be complete by October 2023, with the remainder of the trial expected to wrap-up by October 2024.
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