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the Preliminary data, progress of this study and the adjustment of the pipeline and strategy .
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| Name | Class |
|---|---|
| Nanjing Legend Biotech Co. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chimeric Antigen Receptor T cell | Experimental | LCAR-C182A Cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCAR-C182A cells | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | 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. | 90 days post infusion |
| MTD)/ RP2D regimen finding | Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) | 90 days post infusion |
| Transgene Levels of LCAR-C182A CAR-T Cells | Transgene Levels of LCAR-C182A CAR-T Cells using sensitive assay methods will be assessed | 2 years post infusion |
| Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration | Venous blood samples will be collected for measurement of CAR-T positive cellular concentration | 2 years post infusion |
| Systemic Cytokine Concentrations | Serum cytokine concentrations such as IL-2, IL-6, IL-8, 1L-10, TNF-α, IFN-γ will be measured for biomarker assessment | 2 years post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) after administration | The ORR is defined as the proportion of patients with complete or partial response according to Response Evaluation Criteria In Solid Tumors(RECIST) criteria. | 2 years post infusion |
| Duration of remission (DOR) after administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enxiao Li, MD,PhD | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xian Jiaotong University | Xi’an | Shanxi | 710004 | China |
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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. |
| 2 years post infusion |
| Progress Free Survival (PFS) after administration | The PFS is defined as the Time from enrollment until disease progression or death according to Response Evaluation Criteria In Solid Tumors(RECIST) criteria. | 2 years post infusion |
| Overall Survival (OS) after administration | The OS is defined as Time from enrollment until death from any cause according to Response Evaluation Criteria In Solid Tumors(RECIST) criteria. | 2 years post infusion |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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