A Phase 1 Study of LCAR-C182A Cells in the Treatment of Advanced Gastric Cancer and Pancreatic Ductal Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT03890198|
Recruitment Status : Terminated (the Preliminary data, progress of this study and the adjustment of the pipeline and strategy .)
First Posted : March 26, 2019
Last Update Posted : July 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Pancreatic Ductal Adenocarcinoma||Biological: LCAR-C182A cells||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||April 22, 2019|
|Actual Primary Completion Date :||March 6, 2020|
|Actual Study Completion Date :||March 6, 2020|
Experimental: chimeric Antigen Receptor T cell
Biological: LCAR-C182A cells
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.
- Number of Participants With Adverse Events [ Time Frame: 90 days post infusion ]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.
- MTD）/ RP2D regimen finding [ Time Frame: 90 days post infusion ]Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)
- Transgene Levels of LCAR-C182A CAR-T Cells [ Time Frame: 2 years post infusion ]Transgene Levels of LCAR-C182A CAR-T Cells using sensitive assay methods will be assessed
- Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration [ Time Frame: 2 years post infusion ]Venous blood samples will be collected for measurement of CAR-T positive cellular concentration
- Systemic Cytokine Concentrations [ Time Frame: 2 years post infusion ]Serum cytokine concentrations such as IL-2, IL-6, IL-8, 1L-10, TNF-α, IFN-γ will be measured for biomarker assessment
- Overall response rate (ORR) after administration [ Time Frame: 2 years post infusion ]The ORR is defined as the proportion of patients with complete or partial response according to Response Evaluation Criteria In Solid Tumors（RECIST) criteria.
- Duration of remission (DOR) after administration [ Time Frame: 2 years post infusion ]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.
- Progress Free Survival (PFS) after administration [ Time Frame: 2 years post infusion ]The PFS is defined as the Time from enrollment until disease progression or death according to Response Evaluation Criteria In Solid Tumors（RECIST) criteria.
- Overall Survival (OS) after administration [ Time Frame: 2 years post infusion ]The OS is defined as Time from enrollment until death from any cause according to Response Evaluation Criteria In Solid Tumors（RECIST) criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890198
|The First Affiliated Hospital of Xian Jiaotong University|
|Xi'an, Shanxi, China, 710004|
|Principal Investigator:||Enxiao Li, MD,PhD||First Affiliated Hospital Xi'an Jiaotong University|