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2025-12-04

Juncell Therapeutics' GC101 TIL: RCT for Late-line Melanoma Debuts in ESMO-Asia

From December 5th to 7th, 2025, the European Society for Medical Oncology Asia Congress (ESMO-Asia) will be grandly held in Singapore. As a top-tier international academic event focusing on the global field of oncology diagnosis and treatment, this congress aims to gather world-class experts, focus on the characteristics of tumor incidence in the Asia-Pacific region, share cutting-edge new technologies and progress in diagnosis and treatment in the oncology field, and promote international academic exchange and cooperation.

 

On December 5th, ESMO-Asia will officially announce the research protocol of Juncell Therapeutics' pivotal Phase II clinical trial (codenamed MIZAR-003) of autologous natural tumor-infiltrating lymphocyte injection (GC101 TIL) for the treatment of patients with advanced melanoma. This study is the world's first registrative randomized controlled trial (RCT) of tumor-infiltrating lymphocyte (TIL) therapy for late-line melanoma, which can provide clinical data support with a higher level of evidence for TIL therapy.

 

MIZAR-003 (NCT04943913) is a pivotal Phase II, multicenter, randomized, open-label, parallel-controlled treatment study designed to evaluate the efficacy and safety of GC101 TIL cell injection in patients with melanoma who failed or were intolerant to PD-1 antibody treatment. The primary endpoint is progression-free survival (PFS) assessed by the Independent Review Committee (IRC).


Abstract Number: #818TiP

Abstract Title: Trial in progress: A Pivotal Phase 2, Randomized, Controlled, Open-Label, Trial (MIZAR-003) to Assess the Efficacy and Safety of GC101 TIL, an Autologous Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy, for Patients with Advanced Anti-PD-1 Refractory Melanoma in Later-Line Therapy

 

Principal Investigator: Professor Jun Guo

Research Institution: ‌Peking University Cancer Hospital‌

Poster Presentation Time: Dec.5 - Dec.7, 2025