The Ministry of Health and Welfare - Food and Drug Administration of Taiwan (TFDA) has officially approved the phase III clinical trial protocol, “Autologous Dendritic Cells/Tumor Antigens (ADCTA-SSC-G1 ) Adjuvant Immunotherapy of Gliotoma Multiforme (GBM)”, submitted by Safe Save Medical Cell Science & Technology Co. Ltd (SSC). The phase III clinical trial is based on the previous phase I/II and phase II trials which showed highly promising results of safety and efficacy (e.g. 5-Yr overall survival of 18.8% for ADCTA-SSC-G1 group vs <5% for the reference group).
This phase III clinical trial supported by SSC plans to recruit 118 patients with recurrent GBM at 7 clinical center/hospitals in Taiwan, including Chang Gung Memorial Hospital-Linkow, Chang Gung Memorial Hospital- Keelung, Chang Gung Memorial Hospital-Chiayi, Chang Gung Memorial Hospital-Kaohsiong, Veterans General Hospital- Taichung, Chi Mei Hospital- Tainan and National Chen-Kung University Hospital.
The senior chief neurosurgeons in the respective hospitals will serve as principal investigators and, with respective clinical teams, take charge of the clinical parts of the trial, while SSC will provide free-of-charge the ADCTA-SSC-G1 therapeutics prepared at the company’s new cGTP/cGLP HEPA-filtered barrier manufacturing facility.
The present multi-center phase III clinical trial will thus provide further evidence that ADCTA-SSC-G1 adjuvant immunotherapy can increase overall survival as well as life-quality in treated GBM patients.