Study of UCLH801 CAR-T Cell Therapy Targeting CDH17 in Adults With Advanced CDH17-Positive Solid Tumors

What this Trial Is About

Researchers are studying UCLH801 cells, a CAR-T cell therapy designed to target CDH17-positive advanced malignant solid tumors. This includes cancers such as colorectal, gastric, pancreatic, biliary tract, neuroendocrine, ovarian, and lung cancers. The main goal is to evaluate the safety and tolerability of these cells, while also assessing their early effects on tumors, how they act in the body, and any immune responses they might cause. The trial is divided into Phase Ia dose-finding and Phase Ib dose-expansion stages. During Phase Ia, patients receive escalating doses of UCLH801 cells, either CDH17 CAR-T cells or FAST LACO-Stim CDH17 CAR-T cells, with doses adjusted based on safety and biological responses. The study uses a 33 design for dose escalation, with intravenous infusions given at specific dose levels. Prior to receiving FAST LACO-Stim CDH17 CAR-T cells, patients undergo lymphodepleting chemotherapy. Phase Ib involves expanding groups of patients with various cancer types at confirmed doses. Participants will be closely monitored for side effects and changes in laboratory tests from the start of infusion through 28 days after. Researchers will measure the safety of the treatment, early tumor responses, pharmacokinetics, pharmacodynamics, and immune reactions for up to two years. The study includes assessments like tumor measurements, blood tests for cell concentrations and antibodies, and survival expectations. Participation lasts through treatment and follow-up periods to gather comprehensive safety and response data.

CDH17 CAR-T Therapy in Advanced Malignant Solid Tumors