SNPMiner Trials by Shray Alag
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SNPMiner Trials (Home Page)
Report for Mutation C182A
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 A Phase 1, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of LCAR-C182A, an Anti-Claudin18.2 CAR-T Cell Therapy in Patients With Advanced Gastric Cancer and Pancreatic Ductal Adenocarcinoma
This is an open label, single center, single arm phase 1 study to evaluate the safety , tolerability, pharmacokinetics and efficacy and immunogenicity of LCAR-C182A cells targeting Claudin18.2 in the treatment of patients with advanced gastric cancer and Pancreatic Ductal Adenocarcinoma.
NCT03890198 Conditions
- Gastric Cancer
- Pancreatic Ductal Adenocarcinoma
Interventions
- Biological: LCAR-C182A cells
MeSH:Adenocarcinoma Stomach Neoplasms
HPO:Neoplasm of the stomach
A Phase 1, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of LCAR-C182A, an Anti-Claudin18.2 --- C182A ---
A Phase 1 Study of LCAR-C182A Cells in the Treatment of Advanced Gastric Cancer and Pancreatic Ductal Adenocarcinoma This is an open label, single center, single arm phase 1 study to evaluate the safety , tolerability, pharmacokinetics and efficacy and immunogenicity of LCAR-C182A cells targeting Claudin18.2 in the treatment of patients with advanced gastric cancer and Pancreatic Ductal Adenocarcinoma. --- C182A ---
A Phase 1 Study of LCAR-C182A Cells in the Treatment of Advanced Gastric Cancer and Pancreatic Ductal Adenocarcinoma This is an open label, single center, single arm phase 1 study to evaluate the safety , tolerability, pharmacokinetics and efficacy and immunogenicity of LCAR-C182A cells targeting Claudin18.2 in the treatment of patients with advanced gastric cancer and Pancreatic Ductal Adenocarcinoma. --- C182A --- --- C182A ---
Transgene Levels of LCAR-C182A CAR-T Cells. --- C182A ---
Transgene Levels of LCAR-C182A CAR-T Cells using sensitive assay methods will be assessed. --- C182A ---
Primary Outcomes
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: 90 days post infusionDescription: Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)
Measure: MTD）/ RP2D regimen finding Time: 90 days post infusionDescription: Transgene Levels of LCAR-C182A CAR-T Cells using sensitive assay methods will be assessed
Measure: Transgene Levels of LCAR-C182A CAR-T Cells Time: 2 years post infusionDescription: 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: 2 years post infusionDescription: Serum cytokine concentrations such as IL-2, IL-6, IL-8, 1L-10, TNF-α, IFN-γ will be measured for biomarker assessment
Measure: Systemic Cytokine Concentrations Time: 2 years post infusionSecondary Outcomes
Description: The ORR is defined as the proportion of patients with complete or partial response according to Response Evaluation Criteria In Solid Tumors（RECIST) criteria.
Measure: Overall response rate (ORR) after administration Time: 2 years post infusionDescription: The DOR is defined as the time between the initial onset of complete or partial remission and the onset of disease progression in patients with objective remission according to Response Evaluation Criteria In Solid Tumors（RECIST) criteria.
Measure: Duration of remission (DOR) after administration Time: 2 years post infusionDescription: 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: Progress Free Survival (PFS) after administration Time: 2 years post infusionDescription: The OS 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) after administration Time: 2 years post infusion