A Phase I Platform Study of Target-Based Screened CAR-Macrophages for the Treatment of Advanced Malignant Tumors

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

This study adopts a single-arm, open-label, single-center, dose-escalation platform clinical trial design, which is constructed based on an adenovirus vector delivery system. The primary objective of this trial is to systematically evaluate the safety, tolerability, pharmacokinetic profiles, and preliminary anti-tumor activity of the investigational CAR-M (chimeric antigen receptor-macrophage) injection in patients with advanced solid tumors. The investigational product targets multiple specific antigens, including but not limited to HER2 (human epidermal growth factor receptor 2), PSMA (prostate-specific membrane antigen), and FAP (fibroblast activation protein). The trial is designed to be implemented in a cohort-based manner, with strict enrollment criteria and screening procedures to ensure the rationality and scientificity of cohort grouping. Specifically, all potential participants will first undergo comprehensive screening, which mainly includes two core aspects: target antigen detection and indication confirmation. For target antigen detection, qualified detection techniques will be used to verify the expression level of the target antigen in the patient's tumor tissue or related samples, ensuring that the patient's tumor expresses the corresponding target antigen targeted by the CAR-M injection in the cohort. For indication confirmation, the patient's clinical diagnosis, tumor stage, previous treatment history, and other relevant clinical data will be reviewed in detail to confirm that the patient meets the advanced solid tumor indication requirements corresponding to the cohort. Only patients who pass both target antigen screening and indication screening will be enrolled into the corresponding cohort according to the matching relationship between the target antigen they express and the indication. Each cohort will focus on evaluating the investigational CAR-M injection targeting a specific antigen in patients with corresponding advanced solid tumors, and the dose-escalation process will be carried out step by step in accordance with pre-set trial protocols, so as to gradually clarify the safe dose range, pharmacokinetic characteristics, and preliminary anti-tumor effect of the product in different populations.