NCT05366478

A Clinical Study of LM103 Injection in the Treatment of Advanced Solid Tumors

A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of LM103 Injection in the Treatment of Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Suzhou BlueHorse Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of LM103 Injection in patients with advanced solid tumors. The purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity.

Detailed description

This is an investigator initiated , single-arm, open-label ,exploratory study of LM103 Injection in patients with advanced solid tumors. Expanded TILs will be transferred to the patient after chemotherapy with cyclophosphamide and fludarabine. LM103 will be administered as a single dose on day 1. TIL transfer will be combined with IL-2 treatment. This study is planned to enroll 9-15 patients with advanced solid tumors.

Conditions

• Melanoma
• Non Small Cell Lung Cancer
• Cervical Carcinoma

Interventions

Type	Name	Description
DRUG	Autologous tumor infiltrating lymphocytes (TILs)	A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients will be infused with LM103 Injection followed by IL-2.

Timeline

• Start date: 2022-05-30
• Primary completion: 2024-05-30
• Completion: 2029-05-30
• First posted: 2022-05-09
• Last updated: 2022-08-02

Locations

1 site across 1 country: China