Dual-targeting CLDN18.2 and PD-L1 CAR-T for Patients with CLDN18.2-positive Advanced Solid Tumors
This study tests a new type of immunotherapy using CAR-T cells that are engineered to recognize and attack cancer cells expressing CLDN18.2 and PD-L1 proteins. These proteins are commonly found in advanced gastric cancer and pancreatic cancer. The goal is to determine if this dual-targeting approach is safe and effective in treating advanced solid tumors.
Key Objective: This trial investigates whether targeting two cancer-promoting proteins simultaneously can improve the body's immune response against advanced solid tumors.
Who to Consider: Patients with advanced solid tumors (especially gastric or pancreatic cancer) that are positive for CLDN18.2 and have limited other treatment options should consider this trial.
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Male or female, Age 18-75 years old; 2. 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; 3. Must have CLDN18.2-positive tumor expression ≥10% as determined by the CLDN18.2 IHC assay; 4. Estimated life expectancy \> 3 months (according to investigator's judgement); 5. At least 1 measurable lesion per RECIST 1.1; 6. The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 7. Sufficient venous access for leukapheresis collection and no other contraindications to leukapheresis; 8. Patients should have reasonable CBC counts, renal and hepatic functions; 9. No other serious diseases (autoimmune diseases or any immune deficiency dise