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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
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.
The First Affiliated Hospital of Xian Jiaotong University
Xi’an, Shanxi, China
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.
Time frame: 90 days post infusion
MTD)/ RP2D regimen finding
Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 years post infusion
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.
Time frame: 2 years post infusion
Duration of remission (DOR) after administration
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 2 years post infusion