Objective to evaluate the safety and efficacy of ly011 cell injection in the treatment of advanced gastric adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
CAR-T
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGMaximum tolerable dose(MTD)
MTD determination will based on the incidence of reported adverse events (including dose-limiting toxicities) and abnormal laboratory test results.
Time frame: 1month
Incidence of Treatment-Emergent Adverse Events [Safety]
AEs according to CTCAE v 5.0.
Time frame: 2 years
Overall Response rate(ORR)
the proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria
Time frame: 2 years
Area under the curve from time 0 to the last time point (AUC0-t)
Area under the curve from time 0 to the last time point for serum CAR-T cells
Time frame: 1 years
Apparent clearance (CL)
Apparent clearance for serum CAR-T cells
Time frame: 1 years
Maximum concentration (Cmax)
Maximum concentration for serum CAR-T cells
Time frame: 1 years
Half-life (T½)
Half-life for serum CAR-T cells
Time frame: 1 years
Area under the serum concentration-time curve (AUC0-inf)
Area under the serum concentration-time curve for serum CAR-T cells
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1 years
Time to maximum concentration (Tmax)
Time to maximum concentration for serum CAR-T cells
Time frame: 1 years
Terminal elimination rate constant (λz)
Terminal elimination rate constant for serum CAR-T cells
Time frame: 1 years
Area under the curve above baseline of ANC [ANC_AUC(0-tlast)]
Area under the curve above baseline of ANC for serum CAR-T cells
Time frame: 1 years