NCT06956261

NW-301 TCR-T in Patients With Advanced Solid Tumor

Open-label, Single-arm, Phase 1 Clinical Trial to Evaluate the Safety and Efficacy of Autologous TCR-T Cell Therapy in Subjects With Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

An open label, two cohorts, multiple dose exploratory clinical study to independently evaluate the safety, efficacy, and pharmacokinetics of autologous anti-KRAS G12V/G12D mutation T-cell Receptor T cell in advanced solid tumor

Detailed description

This study is an open, two cohorts single infusion, dose escalation/dose regimen finding study to independently assess the safety and pharmacokinetics of KRAS G12V/G12D mutation TCR-T cell therapies, and to obtain the preliminary efficacy results in subjects who have been diagnosed with advanced solid tumor with KRAS G12V/G12D mutation and failed to standard systemic treatment

Conditions

• Tumor, Solid

Interventions

Type	Name	Description
DRUG	NW-301V	TCR-T T cell targeting KRAS G12V mutation
DRUG	Drug: NW-301D	TCR-T T cell targeting KRAS G12D mutation

Timeline

• Start date: 2025-05-10
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-05-04
• Last updated: 2025-05-04

Locations

2 sites across 1 country: China