Phase 1 trial of multi-antigen stimulated cell-therapy-I with or without chemotherapy as first-line maintenance in advanced sarcoma

Advanced sarcomas lack effective maintenance therapies after first-line chemotherapy. Multi-antigen stimulated cell therapy-I (MASCT-I) is a novel immunotherapy integrating dendritic cell vaccination with adoptive T-cell transfer. A phase 1 trial at Sun Yat-sen University Cancer Center (Guangzhou, China) evaluated MASCT-I with or without ifosfamide as maintenance treatment for advanced sarcoma. Thirty-one patients with disease control after chemotherapy received MASCT-I alone (n=17) or with ifosfamide (n=14). The primary endpoint was safety. Treatment was well tolerated with no treatment-related deaths. The median progression-free survival was 9.5 months from maintenance initiation and 16.2 months from first-line chemotherapy start. The median overall survival was 33.8 months. Combination with ifosfamide numerically improved survival outcomes compared to monotherapy. Six of the seven patients who maintained progression-free status over 4 years exhibited robust immune activation. The authors conclude that MASCT-I alone or in combination with chemotherapy is a promising maintenance therapy for advanced sarcoma.