SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT03890198

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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 Gastric Cancer Pancreatic Ductal Adenocarcinoma
MeSH:Adenocarcinoma Stomach Neoplasms
HPO:Neoplasm of the stomach

1 Interventions

Name: LCAR-C182A cells

Description: Patients receive fludarabine (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. PS:The specific dose of fludarabine and cyclophosphamide is adjusted according to the individual condition of the subject and the judgment of the investigator.
Type: Biological
Group Labels: 1

chimeric Antigen Receptor T cell


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 infusion

Description: Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)

Measure: MTD)/ RP2D regimen finding

Time: 90 days post infusion

Description: 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 infusion

Description: 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 infusion

Description: 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 infusion

Secondary 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 infusion

Description: 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 infusion

Description: 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 infusion

Description: 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

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 C182A

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 ---



HPO Nodes


HPO: