A Phase I, Open-label, Single-arm, Dose-escalation and Expansion Study of Specific Dual-targeting CLDN18.2 and PD-L1 CAR-T for Patients with CLDN18.2-positive Advanced Solid Tumors
Claudin18.2(CLDN18.2) is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in many solid tumors, especially in gastric cancer and pancreatic cancer. The CLDN18.2/PD-L1 dual-targeting CAR-T will be investigated in patients with CLDN18.2-positive advance solid tumors.
• Male or female, Age 18-75 years old;
• Patients with pathologically/histologically confirmed diagnosis of solid tumors (such as advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma and pancreatic adenocarcinoma) have received at least once systemic standard treatment and disease progressed; or refused/ cannot tolerate the subsequential standard treatment after the first line treatment;
• Must have CLDN18.2-positive tumor expression ≥10% as determined by the CLDN18.2 IHC assay;
• Estimated life expectancy \> 3 months (according to investigator's judgement);
• At least 1 measurable lesion per RECIST 1.1;
• The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Sufficient venous access for leukapheresis collection and no other contraindications to leukapheresis;
• Patients should have reasonable CBC counts, renal and hepatic functions;
• No other serious diseases (autoimmune diseases or any immune deficiency disease);
⁃ Women of childbearing age must undergo a serum pregnancy test with negative results before screening and infusion and be willing to use effective and reliable method of contraception for at least 12-months after T-cell infusion;
⁃ Men must be willing to use effective and reliable method of contraception and are not allowed to donate sperm for at least 12-months after T-cell infusion;
⁃ Voluntarily participate in the research, understand and sign the informed consent.