Recently, Juncell Therapeutics announced that the first pivotal Phase II registrational clinical trial of GC101 TIL Injection has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of patients with advanced melanoma who have progressed on or are intolerant to PD-1 antibody therapy (NCT06703398).

The trial will be led by Professor Jun Guo, a global authority in the field of melanoma from Beijing Cancer Hospital, as the principal investigator, and will conduct a multi-center clinical study nationwide.

Dr. Huajun Jin, Founder, CEO & CTO of Juncell stated，The advancement of GC101 into a pivotal Phase II clinical trial marks a significant milestone in the development of Juncell's innovative TIL therapies. We sincerely appreciate the trust and cooperation of the trial participants and their families, and we are grateful for the efforts and dedication of the clinical researchers! We look forward to further clinical studies of GC101, with the hope of benefiting more melanoma patients in the future. 

About Melanoma 

In China, the mortality rate of melanoma is higher and the incidence rate is increasing year by year. Compared with European or American, there are significant differences in the characteristics of melanoma in Chinese: about 90% of melanoma originates in the skin among European and American. In Asian, about 50% of melanoma originates at the extremity and 20-30% in the mucous membrane. In contrast, melanoma of the extremity and mucosal type has a worse prognosis. 

About GC101 

Developed based on Juncell Therapeutics' independently developed, world-leading DeepTIL™cell enrichment and expansion platform, GC101 is the fastest-advancing TIL therapy in Juncell's pipeline and the world's first natural TIL therapy that eliminates the need for lymphodepletion and IL-2 injections.  GC101 has been validated for its clinical efficacy and safety which greatly improves the safety and accessibility of TIL therapy. 

About MIZAR-003 

MIZAR-003 is to investigate the efficacy and safety of autologous tumor infiltrating lymphocyte (GC101 TIL) therapy versus investigator's choice of chemotherapy in patients with advanced melanoma.