Juncell Therapeutics Initiates Phase II Clinical Trial of Innovative GC101 TIL Therapy for NSCLC, Being the First in China
March 25–28, 2026, The European Lung Cancer Congress (ELCC) 2026, jointly organized by the European Society for Medical Oncology (ESMO) and the International Association for the Study of Lung Cancer (IASLC), will convene in Copenhagen, Denmark.
As one of the most influential global scientific conferences in lung cancer, ELCC brings together leading experts in thoracic oncology and serves as a premier platform for exchanging cutting-edge research, clinical data, and educational best practices.
At this year's congress, Juncell Therapeutics will formally present the study protocol for its Phase Ib clinical trial (MIZAR-005) of autologous natural tumor-infiltrating lymphocyte injection (GC101) in patients with advanced non-small cell lung cancer (NSCLC).
Abstract Number: #219eTiP
Abstract Title: Trial in progress: A Phase Ib, Open-label, Single-arm Trial of Autologous Natural Tumor-Infiltrating Lymphocyte Injection (GC101) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) (MIZAR-005)
Principal Investigator: Professor Shun Lu
Research Institution: Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University
Poster Presentation Time: Mar.25 - Mar.28, 2026
Phase II Clinical Trial of GC101 for Lung Cancer Officially Initiated
Building on the exploratory findings and safety validation from the Phase Ib clinical trial, Juncell Therapeutics has officially advanced into the Phase II clinical study of GC101 for the treatment of advanced NSCLC. The MIZAR-005 trial has been successively initiated at the leading principal investigator site Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University and Hunan Cancer Hospital and many sub-centers nationwide.
Lung cancer ranks first among all malignant tumors in terms of incidence and mortality in China. Non-small cell lung cancer (NSCLC) accounts for 80%-85% of all lung cancer cases. Approximately 70% of patients are diagnosed at an advanced stage of the disease, with a 5-year survival rate of merely 15%. While TIL therapy has demonstrated promising prospects in the treatment of solid tumors, conventional TIL regimens rely on high-intensity lymphodepleting chemotherapy and high-dose IL-2 administration, with prominent adverse event being the core bottleneck restricting its widespread clinical application.
Addressing the industry bottlenecks of conventional TIL therapy, Juncell Therapeutics has independently developed GC101, the world's first innovative native TIL therapy that requires no high-intensity lymphodepleting chemotherapy and no IL-2 administration. The therapy has demonstrated robust efficacy and a favorable safety profile in Phase I clinical research. Clinical data showed that in advanced patients with a median of three prior lines of treatment, GC101 achieved an objective response rate (ORR) of 41.7% and a disease control rate (DCR) of 66.7%, with a 12-month overall survival rate of 66.7% (95% CI: 33.7%, 86.0%). With a median follow-up of 13.0 months (range: 1.5–31.1 months), the median overall survival (mOS) has not yet been reached.
Professor Lu Shun, Director of the Department of Oncology at Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University, stated in recent years, targeted therapy and immunotherapy have achieved remarkable progress in the treatment of advanced NSCLC; nevertheless, multiple challenges remain, including overcoming drug resistance mechanisms and addressing tumor heterogeneity. For patients with advanced NSCLC who experience treatment failure after first-line therapy, the clinical benefits offered by subsequent immunotherapy and chemotherapy are limited. There remains a significant unmet clinical need for cell therapies with a superior safety profile and durable therapeutic efficacy.
Preliminary clinical trial data of GC101 from Juncell Therapeutics has demonstrated promising efficacy outcomes. Further exploration is anticipated to unlock the full potential of TIL therapy in the treatment of NSCLC patients. It is expected that this innovative TIL therapy will benefit a broader population of lung cancer patients and substantially improve patients' quality of life.