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.
Parallel
CAR-M
Biological/VaccineIV
Incidence of Dose-Limiting Toxicities (DLTs)
Incidence and characteristics of DLTs graded according to NCI CTCAE v5.0. The DLT observation period is 28 days post-infusion.
Incidence of Adverse Events (AEs)
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI CTCAE v5.0.
Determine and characterize the optimal dosing regimen (full dose vs. split dose).
Split dose is superior for CAR-M optimal dosing: it mitigates acute toxicities (e.g., cytokine responses) via gradual immune activation, sustains robust CAR-M cell expansion and in vivo persistence, and improves safety in high-risk patients. Full dose enables rapid therapeutic efficacy in low-risk cohorts with intact organ function. Optimal regimens are tailored to patient baseline status/indications, validated via dose-escalation trials for balance of safety and anti-tumor activity.
To obtain the pharmacokinetic (PK) characteristics of CAR-M (targeting HER2, PSMA, FAP, etc.) injection in humans.
Quantitative Assessment of CAR Transgene Copy Number in Peripheral Blood Cells
Serum Cytokines of CAR-M (targeting HER2, PSMA, FAP, etc.) injection in humans.
Serum levels of IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α, and IL-17 will be measured as systemic pharmacodynamic (PD) biomarkers and potential predictors of cytokine release syndrome (CRS).
Tumor Microenvironment (TME) Infiltration
Tumor biopsies will be collected to evaluate CAR-M infiltration within the tumor microenvironment.
Dynamic Monitoring of Target Expression
Dynamic changes in HER2, PSMA, and FAP expression (IHC H-score variation) will be analyzed as pharmacodynamic (PD) biomarkers, while baseline target expression status will be used as an eligibility criterion.
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