SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03890198

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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

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.

NCT03890198 Gastric Cancer Pancreatic Ductal Adenocarcinoma
MeSH: Adenocarcinoma Stomach Neoplasms
HPO: Neoplasm of the stomach

1 Interventions

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: Biological

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: within 90 days after cell infusion

Description: 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 years

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: 4 years

Description: 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 years

Secondary Outcomes

Description: 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 years

Description: 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 years

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: progression-free survival(PFS)

Time: 4 years

Description: 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 years

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 C182A

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 ---



HPO Nodes


HPO:
Neoplasm of the stomach
Genes 59
CDKN2A KRAS CDKN2B CDKN2D STK11 MSH6 TREX1 ERBB2 BMPR1A DLC1 NRAS MGMT ACD KLF6 PDGFRA PIK3CA POT1 SRC BUB1 BUB1B MC1R MITF CHEK2 PTCH2 APC MLH1 PRKAR1A FLCN CASP10 IRF1 AKT1 RPS20 BCL10 MSH2 FGFR3 MSH3 FGFR2 SEMA4A CTNNB1 DCC PTCH1 BUB3 SUFU CEP57 ENG CDH1 TRIP13 KIT TERT EP300 TERF2IP MUTYH SDHA SDHB SDHC AXIN2 SMAD4 BAP1 CDK4