CDH17 CAR-T Therapy in Advanced Malignant Solid Tumors

The investigational product used in this study, UCLH801 cells, is a CAR-T cell therapy specifically targeting CDH17. The proposed indication includes CDH17-positive advanced solid tumors, such as but not limited to colorectal cancer, gastric cancer, pancreatic cancer, biliary tract tumors, neuroendocrine tumors, ovarian cancer, and lung cancer. The primary objective of this study is to evaluate the safety and tolerability of UCLH801 cells in patients with CDH17-positive advanced malignant solid tumors. The secondary objectives include assessing the preliminary efficacy of UCLH801 cells, their pharmacokinetics and pharmacodynamics in the body, and their immunogenicity. This study aims to observe how the infusion of UCLH801 cells affects patients 's body, including any discomfort or changes in laboratory test results. Additionally, it will evaluate whether UCLH801 cells have any effect on tumor. Furthermore, the study will investigate how UCLH801 cells are metabolized; the mechanisms through which they exert their effects, and how to develops any immune response or rejection against UCLH801 cells.

NCT Number	NCT06937567
Lead Sponsor	Zhejiang University Collaborators: UTC Therapeutics Inc.
Conditions	Biliary Tract Cancer, Colorectal Carcinoma, Gastric Cancer, Metastatic, Pancreatic Adenocarcinoma (Ductal Adenocarcinoma), Multiple Cancer
Enrollment	36 participants
Start Date	2024-12-26
Primary Completion	2028-03-30 (estimated)
Study Completion	2028-05-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-26