This is a single-arm, open-label, single-center, dose-escalation platform clinical trial design. Using an adenovirus vector platform, the study aims to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary anti-tumor activity of investigational CAR-M macrophage injections targeting various antigens (including HER2, PSMA, FAP, etc.) in patients with advanced solid tumors. The clinical trial is designed to be conducted in cohorts, with patients enrolled into respective cohorts based on target antigen and indication screening
Aged 18 to 75 years (inclusive) at the time of signing the informed consent form, with no gender restriction.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Life expectancy of at least 3 months (as assessed by the investigator).
Electrolytes: Corrected calcium, potassium, and magnesium levels within the normal range.
Known hypersensitivity to CAR-M or any of its excipients.
History of severe hypersensitivity to filgrastim (G-CSF) or tocilizumab.
Known history of substance abuse.
A history of ≥ Grade 3 immune-related adverse events (irAEs) or ≥ Grade 2 immune-related myocarditis following prior immunotherapy.