NCT05344976

MSLN STAR-T Cells in the Treatment of Advanced Malignant Solid Tumors

An Exploratory Clinical Study on the Safety and Efficacy of MSLN STAR-T Cells in Advanced Malignant Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, single-arm, open-label Phase I study to evaluate the safety and efficacy of MSLN STAR-T cell immunotherapy in the treatment of advanced malignant solid tumors.

Detailed description

This study is a single-center, dose-escalation, prospective, exploratory study to evaluate the safety and efficacy of MSLN STAR-T cells in patients with hepatocellular carcinoma. The study is divided into two phases: dose escalation and dose expansion. The total duration of each subject's participation in the study is expected to be 24 months, including the screening period, non-myeloablative chemotherapy pretreatment, cell infusion-observation period, and follow-up period.

Interventions

Type	Name	Description
BIOLOGICAL	MSLN STAR-T cells	Patients with advanced MSLN-positive solid tumors will be recruited, and autologous-derived MSLN-STAR-T cells will be infused intravenously at escalating doses of 1×10\^7-1×10\^8 MSLN-STAR-T cells. The CAR-T ratio will be monitored at predetermined times (day 0, day 4, day 7, day 10, day 14, day 28).

Timeline

• Start date: 2022-04-14
• Primary completion: 2024-10-14
• Completion: 2026-02-01
• First posted: 2022-04-25
• Last updated: 2022-04-25