drugset / Trial / NCT06101082

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

NCT06101082 ↗

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2024-01-16
Primary completion
2026-10-19
Completion
2026-10-19

Drugs

EvaluationDrugModalityDoseRoute
Subject anti-HER2-CAR-T cell Cell therapy 1e+06 cells/kg Intravenous
Subject anti-HER2-CAR-T cell Cell therapy 3e+06 cells/kg Intravenous
Subject anti-HER2-CAR-T cell Cell therapy 1e+07 cells/kg Intravenous

Indications