This is an open label,phase 1 study,to evaluate the safety , tolerability and efficacy of LCAR-C182A/LCAR-C182B/LCAR-C182C cells targeting Claudin 18.2 in the treatment of patients with advanced gastric cancer and Pancreatic Ductal Adenocarcinoma.
Name: LCAR-C182A/LCAR-C182B/LCAR-C182C cells
Description: Patients receive fludarabine phosphate(3×300 mg/m^2) and cyclophosphamide (3×30 mg/m^2) IV on days -5 to-3, and then Patients receive CAR-T cells IV as multiple infusions.Type: Biologicalchimeric Antigen Receptor T cell
Description: An adverse event is any untoward medical event that occurs in a participant administered an investigational product,and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measure: Number of Participants With Adverse Events Time: within 90 days after cell infusionDescription: Transgene Levels of LCAR-C82CAR-T Cells using sensitive assay methods will be assessed
Measure: Transgene Levels of LCAR-C82 CAR-T Cells Time: 4 yearsDescription: Venous blood samples will be collected for measurement of CAR-T positive cellular concentration
Measure: Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration Time: 4 yearsDescription: Serum cytokine concentrations such as Interleukin IL-6, TNF-α, IL-10, 1L-15, IFN-γ,will be measured for biomarker assessment
Measure: Systemic Cytokine Concentrations Time: 4 yearsDescription: The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to Response Evaluation Criteria In Solid Tumors(RECIST) criteria.
Measure: Overall Response Rate (ORR) Time: 4 yearsDescription: The DOR is defined as the time from documentation of tumor response to disease progression according to Response Evaluation Criteria In Solid Tumors(RECIST) criteria.
Measure: Duration of Overall Response(DOR) Time: 4 yearsDescription: The PFS is defined as the Time from enrollment until disease progression or death according to Response Evaluation Criteria In Solid Tumors(RECIST) criteria.
Measure: progression-free survival(PFS) Time: 4 yearsDescription: The PFS is defined as Time from enrollment until death from any cause according to Response Evaluation Criteria In Solid Tumors(RECIST) criteria.
Measure: Overall Survival (OS) Time: 4 yearsSingle Group Assignment
There is one SNP
A Phase 1, Open-Label Study,to Evaluate the Safety, Tolerability and Efficacy of LCAR-C182A/LCAR-C182B/LCAR-C182C Cells,a Chimeric Antigen Receptor T-cell (CAR-T) Targeting Claudin18.2, in the Treatment of Advanced Gastric Cancer and Pancreatic Ductal Adenocarcinoma. --- C182A ---
A Phase 1 Study of LCAR-C182A/LCAR-C182B/LCAR-C182C Cells,a Chimeric Antigen Receptor T-cell (CAR-T) This is an open label,phase 1 study,to evaluate the safety , tolerability and efficacy of LCAR-C182A/LCAR-C182B/LCAR-C182C cells targeting Claudin 18.2 in the treatment of patients with advanced gastric cancer and Pancreatic Ductal Adenocarcinoma. --- C182A ---
A Phase 1 Study of LCAR-C182A/LCAR-C182B/LCAR-C182C Cells,a Chimeric Antigen Receptor T-cell (CAR-T) This is an open label,phase 1 study,to evaluate the safety , tolerability and efficacy of LCAR-C182A/LCAR-C182B/LCAR-C182C cells targeting Claudin 18.2 in the treatment of patients with advanced gastric cancer and Pancreatic Ductal Adenocarcinoma. --- C182A --- --- C182A ---