Shanghai Juncell Therapeutics has announced that the National Medical Products Administration’s Center for Drug Evaluation (CDE) has approved the first pivotal Phase II registration clinical trial for its GC101 TIL injection. The trial, designated as NCT06703398, is for the treatment of advanced melanoma patients who have progressed or are intolerant to PD-1 antibody therapy. The study will be led by Professor Guo Jun, a global authority in melanoma treatment at Beijing Cancer Hospital, and will be conducted as a multicenter clinical research across China.
GC101: A Breakthrough in TIL Cell Therapy
GC101 is the world’s first natural TIL (tumor infiltrating lymphocyte) cell therapy that does not require lymphodepletion or IL-2 injections. This milestone marks a significant breakthrough in the field of solid tumor cell therapy. Juncell Therapeutics, based on its proprietary DeepTIL® cell expansion platform, has developed GC101 to cultivate a sufficient number of highly active TIL cells without the need for high concentrations of IL-2 and feeder cells, and it is not dependent on IL-2.
Clinical Efficacy and Safety Profile of GC101
Despite being primarily tested on more challenging acral and mucosal melanoma patients, GC101 has shown an objective response rate (ORR) similar to Lifileucel, with a median progression-free survival (mPFS) extended by over a month. In terms of safety, patients treated with GC101 have been managed in regular wards without treatment-related deaths or ICU admissions, and no patients have required blood cell transfusions, with hospital stays reduced by approximately 80%.
About GC101 and DeepTIL® Platform
GC101 is developed based on Juncell Therapeutics’ independently developed and globally leading DeepTIL® cell enrichment and expansion platform. It is the fastest progressing TIL therapy pipeline within the company and the first natural TIL therapy that does not require lymphodepletion or IL-2 injections. Clinical data has shown that GC101 has an objective response rate (ORR) of over 35% for various types of advanced solid tumors, with four patients achieving complete response (CR) and remaining disease-free for the longest period exceeding three years.-Fineline Info & Tech
