NCT06652243

Clinical Study of SN301A Injection in the Treatment of Hepatocellular Carcinoma

An Early Clinical Study to Evaluate the Safety and Efficacy of SN301A Cell Injection in the Treatment of Subjects with Glypican-3 (GPC3)-Positive Advanced Hepatocellular Carcinoma

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label study of safety, tolerability, and anti-cancer activity of SN301A (an off-the-shelf CAR NK cell therapy) in patients with glypican-3 (GPC3)-positive advanced hepatocellular carcinoma.

Detailed description

This study is a single-arm, open-label, modified 3+3 dose-escalation early exploratory clinical study to evaluate the safety, tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) of SN301A cell injection in the treatment of subjects with glypican-3 (GPC3)-positive advanced hepatocellular carcinoma, and evaluate the efficacy of SN301A cell injection in the treatment of subjects with GPC3-positive advanced hepatocellular carcinoma.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
BIOLOGICAL	SN301A	SN301A is an investigational off-the-shelf CAR NK cell therapy, armed with calibrated release (cr)IL15, designed to selectively target and treat GPC3 expressing advanced hepatocellular carcinoma. Subjects will receive lymphodepletion pretreatment (Fludarabine/Cyclophosphamide), three SN301A intravenous infusions in a cycle (D0, D7, D14), with each subject receiving a maximum of 3 cycles.

Timeline

• Start date: 2024-11-18
• Primary completion: 2026-10-31
• Completion: 2027-10-31
• First posted: 2024-10-22
• Last updated: 2024-11-25

Locations

1 site across 1 country: China