An open label, dose-escalation clinical study to evaluate the safety, anti-tumor activity and pharmacokinetics/pharmacodynamic (PK/PD) of NW-301VT in subjects with advanced solid tumor.
Using a modified 3+3 dose escalation design, this study will enroll \~9 subjects to characterize the safety and preliminary anti-tumor activity of NW-301VT . Eligible subjects will undergo leukapheresis for autologous cell product manufacturing, and will receive a 3-day lymphodepleting regimen consisting of cyclophosphamide and fludarabine, followed by a single-dose intravenous infusion of NW-301VT. following this intervention, subjects will be monitored for safety and AE, and tumor evaluation will be performed at pre-specified timepoints per protocol.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
TCR-T cell targeting KRAS G12V mutation
The First Affiliated Hospital of Zhejiang University school of Medicine
Hangzhou, Zhejiang, China
Dose-limiting toxicity (DLT)
Safety
Time frame: 28 days following NW-301VT infusion
Objective response rate (ORR)
complete response (CR) and partial response (PR) based on best overall response (BOR), locally assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Through study completion, an average of 2 years
Duration of response (DOR)
CR and PR, locally assessed using RECIST v1.1
Time frame: Through study completion, an average of 2 year
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