An open label, two-cohort, dose-escalation clinical study to evaluate the safety, anti-tumor activity and pharmacokinetics/pharmacodynamic (PK/PD) of NW-301V and NW-301D in subjects with advanced solid tumor.
Using a modified 3+3 dose escalation design, this study will enroll \~9subjects to characterize the safety and preliminary anti-tumor activity of NW-301V and NW-301D in each cohort respectively. 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-301V or NW-301D. after NW-301V or NW-301D infusion, a low dose of IL-2 will be given subcutaneously for up to 10 days. 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
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGDose-limiting toxicity (DLT)
Safety
Time frame: 28 days of single 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 the study completion, with average of 2 years
Duration of response (DOR)
CR and PR, locally assessed using RECIST v1.1
Time frame: through the study completion, with average of 2 years
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