Chimeric Therapeutics (CHM) Study update summary

Study overview and context

• Data from the CHM CDH17/CHM-2101 phase I/II open-label trial was presented at ASCO, focusing on a Cadherin 17-directed CAR T-cell therapy for advanced gastrointestinal cancers, including colorectal, gastric, and neuroendocrine tumors.

• The study is in the dose escalation phase (3+3 design), currently at Dose Level 3 (450 million cells), with FDA approval to move into phase II and ongoing enrollment.

• The therapy targets a significant unmet need, as colon cancer is the leading cause of cancer death in young adults in the U.S.

• Manufacturing success rate has been 100%, exceeding industry standards.

• Recruitment demand is high, especially among younger colon cancer patients, and commercial interest has increased.

Study design and objectives

• The study aims to determine the recommended Phase 2 dose, assess safety, and measure objective response and disease control rates.

• Participants receive lymphodepleting chemotherapy followed by a single infusion of CHM-2101.

• Primary outcomes include dose-limiting toxicity and adverse event rates; secondary outcomes include response rates, progression-free survival, and overall survival.

Patient demographics and eligibility

• Eligible patients are adults (18–85 years) with advanced GI cancers, ECOG ≤1, and measurable disease for Phase 2.

• Average patient age is just under 50, with an even gender split.

• Patients have received between 1 and 12 prior lines of chemotherapy, all with Stage IV metastatic disease.

• Exclusions include prior CDH17-targeted therapy, unresolved toxicities, CNS metastases, and significant comorbidities.