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Phase 1 Study of NW-301V TCR-T Cells in Advanced Solid Tumors With KRAS G12V Mutation
Sponsor: Neowise Biotechnology
Summary
This is a single-arm, multicenter, open-label, Phase 1a/1b dose-escalation and dose-expansion study designed to evaluate the safety, preliminary antitumor activity, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of NW-301V, an autologous TCR-T cell therapy, in Chinese adult participants with advanced malignant solid tumors harboring a KRAS G12V mutation.
Official title: A Single-Arm, Multicenter, Open-Label, Phase Ia/Ib Clinical Study of NW-301V in Advanced Solid Tumors Harboring KRAS G12V Mutations
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2026-10
Completion Date
2033-03
Last Updated
2026-10-15
Healthy Volunteers
No
Conditions
Interventions
Fludarabine
Used for lymphodepletion
Cyclophosphamide
Used for lymphodepletion
NW-301V
NW-301V is an autologous TCR-T cell therapy targeting KRAS G12V in the context of HLA-A\*11:01, administered intravenously after lymphodepletion.
Locations (2)
Beijing Cancer Hosptial
Beijing, Beijing Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China