NCT07207681

Personalized KXV01 TCR Lentinvivo Injection as the Therapy for Advanced Solid Tumors

A Phase I Clinical Study of KXV01 TCR Lentinvivo Injection on Safety, Tolerability, and Efficacy in Patients With Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KXV01 TCR Lentinvivo for patients with advanced solid tumors.

Detailed description

In recent years, the field has found that patient-specific anti-tumor treatment technologies have increasingly significant clinical application prospects and clinical value. Patient-specific anti-tumor in vivo TCR gene therapy is an advanced therapeutic strategy that can specifically recognize tumor neoantigens. This strategy is not restricted by patients' HLA typing nor by the type of indication. This investigator-initiated clinical study aims to evaluate KXV01 TCR Lentinvivo, the third-generation self-inactivating lentiviral vector that carries patient-derived personalized tumor reactive TCR, in patients with advanced solid tumors. The study employs a BOIN design to assess safety, tolerability, and preliminary efficacy.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	KXV01 TCR Lentinvivo Injection	KXV01 TCR Lentinvivo Injection is one kind of third-generation non-replicative self-inactivating lentivirus vector which carries an effective patient's personalized tumor-reactive TCR.

Timeline

• Start date: 2025-10-15
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2025-10-06
• Last updated: 2025-10-06

Locations

1 site across 1 country: China