Open-Label, Multicenter, Phase 1b Clinical Trial to Evaluate the Safety and Efficacy of Autologous Anti-claudin18.2 Chimeric Antigen Receptor T-Cell Therapy in Patients with Advanced Gastric or Pancreatic Adenocarcinoma
This is an open label, multi-center, Phase 1b clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in patients with advanced gastric or pancreatic adenocarcinoma.
-Evaluate the safety and tolerability of CAR-CLDN18.2 T-cell therapy (CT041) in patients with advanced STAD or PAAD
-Identify the MTD and a RP2D of CT041 therapy in patients with STAD or PAAD
-Evaluate clinical efficacy outcomes with CAR-CLDN18.2 T-cell therapy (CT041) in patients with advanced STAD or PAAD
-Evaluate PK and biodistribution of CAR-CLDN18.2 T-cell therapy (CT041) in patients with STAD or PAAD
-Evaluate the performance of CLDN18.2 IHC assay in patients with STAD or PAAD
-Evaluate anti-CAR-CLDN18.2 T-cell therapy (CT041) drug antibodies in patients with STAD or PAAD
-Determine the efficacy of CAR-CLDN18.2 T-cell therapy (CT041), in terms of ORR in patients with PAAD
-Evaluate the safety and tolerability of CAR-CLDN18.2 T-cell therapy (CT041) in patients with PAAD
-Evaluate additional clinical efficacy outcomes with CAR-CLDN18.2 T-cell therapy (CT041) in patients with PAAD
-Evaluate PK and biodistribution of CAR-CLDN18.2 T-cell therapy (CT041) in patients with PAAD
-Evaluate the performance of CLDN18.2 IHC assay in patients with PAAD
-Evaluate anti-CAR-CLDN18.2 T-cell therapy (CT041) drug antibodies in patients with PAAD
HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infusion
Any uncontrolled active infection
AEs from previous treatment that have not recovered
Patients who have clinically significant thyroid dysfunction
Patients allergic to any drugs of the preconditioning regimen, tocilizumab, dimethyl sulfoxide (DMSO), or CT041 CAR-CLDN18.2 T-cell
Patients who have received prior cellular therapy such as (CAR T, TCR, tumor-infiltrating lymphocytes) or organ transplantation; Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression
Patients with heavy tumor burden such as significant lung disease
Unstable/active ulcer or digestive tract bleeding or recent digestive surgery that may have increased risk of bleeding
Patients who have a history of esophageal or gastric resection with increased risk of bleeding or perforation
Patients requiring anticoagulant therapy such as warfarin or heparin
Patients requiring long-term antiplatelet therapy
Use of prednisone or other equivalent within 14 days before leukapheresis or preconditioning
Anticancer treatment within approximately 2 weeks prior to leukapheresis or approximately 3 weeks before preconditioning
Major surgery less than 1 week prior to leukapheresis or 3 weeks prior to preconditioning
Patients have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients
Patients have clinical significant pulmonary conditions
Patients known to have active autoimmune diseases
Patients with second malignancies in addition to STAD or PAAD
Patients have significant neurologic disorders
Patients are unable or unwilling to comply with the requirements of clinical trial.
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