NCT06120712

A Study of GC101 TIL in Advanced Melanoma (BZ)

An Open, Single-armed, Phase Ib Study to Evaluate the Safety and Efficacy Using Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) in Patients With Advanced Melanoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Shanghai Juncell Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail is expected to be finished in 20 months.

Detailed description

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine and cyclophosphamide.

Conditions

• Tumor Infiltrating Lymphocytes
• Safety
• Melanoma
• Efficacy
• Adverse Drug Event

Interventions

Type	Name	Description
BIOLOGICAL	GC101 TIL	Patients with advanced, recurrent or metastatic melanoma (excluding uveal melanoma) who have failed standard treatment such as PD-1 antibodies (if BRAF mutation is present, BRAF and MEK inhibitors have failed) and are ineligible for resection."

Timeline

• Start date: 2023-11-08
• Primary completion: 2024-11-12
• Completion: 2025-11-12
• First posted: 2023-11-07
• Last updated: 2025-12-23

Locations

1 site across 1 country: China