A Clinical Study Evaluating the Safety and Efficacy of Anti-HER2-CAR-T Cells Injection in Patients With Solid Tumors

This is a single-center, open-label clinical study of anti-HER2-CAR-T cells for HER2+ patients with locally advanced and/or metastatic solid tumors. In this study, a single-dose regimen was designed, and the investigator had the discretion to decide whether the patient received more than once CAR T-cell therapy.This study intends to include HER2+ patients with locally advanced and/or metastatic solid tumors.They will take the anti-HER2-CAR-T cell transfusion after a screening period, mononuclear cell (PBMC) collection, bridging therapy if necessary, and lymphocyte clearance pretreatment period.

NCT Number	NCT06101082
Lead Sponsor	China Medical University, China Collaborators: Shanghai First Song Therapeutics Co., Ltd
Conditions	Solid Tumor
Enrollment	9 participants
Start Date	2024-01-16
Primary Completion	2026-10-19 (estimated)
Study Completion	2026-10-19 (estimated)
Updated on ClinicalTrials.gov	2024-03-06