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NOT YET RECRUITING
NCT07875920
PHASE1

Phase 1 Study of NW-301V TCR-T Cells in Advanced Solid Tumors With KRAS G12V Mutation

Sponsor: Neowise Biotechnology

View on ClinicalTrials.gov

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

Interventions

DRUG

Fludarabine

Used for lymphodepletion

DRUG

Cyclophosphamide

Used for lymphodepletion

BIOLOGICAL

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