drugset / Trial / NCT06224738

Human HER2-targeted Macrophages Therapy for HER2-positive Advanced Gastric Cancer With Peritoneal Metastases

NCT06224738 ↗

NaSingle-groupOpen-labelTreatment

Summary

The goal of this exploratory clinical trial is to evaluate the safety and efficacy of human anti-human epidermal growth factor receptor 2(HER2) Chimeric antigen receptor macrophage cells (CAR-M) in advanced HER2+ gastric cancer. Participants will mobilize bone marrow stem cells and engineer autologous macrophages to express Chimeric antigen receptor (CAR), and CAR-M will be infused intraperitoneally back into the patient for systemic anti-tumor effects.

Timeline

Start
2024-03-01
Primary completion
2025-03-01
Completion
2026-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject anti-HER2 CAR-M cells Cell therapy 3e+08 cells Intrathecal
Subject anti-HER2 CAR-M cells Cell therapy 5e+08 cells Intrathecal
Subject anti-HER2 CAR-M cells Cell therapy 1e+09 cells Intrathecal

Indications