Recently, Juncell Therapeutics announced significant progress in a dose-escalation study of its first natural TIL drug GC101, demonstrating objective efficacy similar to the IIT study in the treatment of various advanced solid tumors. With no DLT (dose-limiting toxicity) observed, The Safety Review Board jointly agreed that the study of GC101 shall proceed to the next stage.

All the subjects enrolled in this dose-escalation study are patients with advanced solid tumors who had failed prior lines of therapy. The first enrolled patient was a 50-year-old male subject with highly malignant melanoma. Inspite of surgical resection combined with adjuvant chemotherapy, lung metastasis was soon observed. The patient further failed in multi-line Chemotherapies, targeted therapy and PD-1 antibody therapy, and showed increasingly shortened drug resistance cycles. Subsequently, the tumor progressed rapidly resulting in multiple metastases to liver, lung and inguinal lymph nodes. At present, this subject has received single infusion of TILs (low dose group, 5e9) and achieved PR efficacy with sustained response completed by the second efficacy evaluation. His target lesion has shrunk by more than 30%.

According to the treatment, only low-intensity lymphodepletion is needed before GC101 infusion, while the conventional TIL therapies usually require high-intensity lymphodepletion pre-treatment. The subjects also have no need to receive any IL-2 injections after the TIL infusion. With the entire TIL therapy completed in general wards, no subject had treatment-related adverse events.

Blood samples collected after TIL infusion were sent to a Independent Clinical Laboratory (ICL) for PK/PD analysis. The amount and proportion of CD8+ T lymphocytes in peripheral blood is one of the key factors affecting the prognosis of tumor patients. The proportion of CD8+ T lymphocytes in all subjects increased significantly after they received GC101 TIL infusion, indicating that the infused TILs had robust in vivo expansion and anti-tumor potential.