Recently, Juncell Therapeutics announced that a Phase II clinical trial has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration for the combination therapy with temozolomide in post-rescetion adjuvant treatment of glioblastoma. GC101 is not only the world's first TIL therapy in high-grade Glioma has been approved, but also a major breakthrough in the field of solid tumor cell therapy.

As the most common primary intracranial tumor, glioma features high malignancy and strong heterogeneity, and is regarded as a tough nut to crack in oncology. Glioblastoma, the most malignant subtype of glioma, has a poor prognosis and an extremely high recurrence rate. Even with standard treatments including surgery, radiotherapy and chemotherapy, the median overall survival (mOS) of patients is merely 14.4 months, with a 5-year survival rate below 10%^[1-3]. Moreover, the postoperative recurrence rate exceeds 90%, and the median survival of patients with postoperative recurrence is only 6-8 months^[4]. More challenging still, the blood‑brain barrier acts like a natural barrier, blocking the vast majority of drugs and severely compromising therapeutic efficacy.

Conventional IL-2-dependent TIL therapy presents some limitations in the treatment of glioblastoma. On one hand, it is quite challenging to cultivate clinical-grade TIL cells from cold tumors. On the other hand, the administration of IL-2 may elevate the risk of serious adverse events, including intracranial edema and cerebral hemorrhage.

Leveraging its proprietary DeepTIL™ technology platform, Juncell Therapeutics has successfully achieved efficient enrichment and expansion of TIL cells from cold tumors. The platform enables the pre-manufacture and cryopreservation of TIL seed cells , which can be rapidly revived, expanded, and reinfused upon tumor recurrence. Its proprietary time-segmented process not only shortens the waiting time but also preserves highly active cytotoxic cells.

GC101 TIL therapy does not require high-intensity lymphodepletion chemotherapy (completely omitting conventional lymphodepleting chemotherapeutics, including cyclophosphamide and fludarabine, in the glioblastoma treatment setting) and IL-2 administration. Upon intravenous administration, it can traverse the blood-brain barrier and mediate targeted tumor cell killing. This regimen thereby presents a simpler, safer and more efficient therapeutic option for glioblastoma.

Reference:

[1] Li D, Chen Y, Wong TF, et al. Management and survival trends for diffuse gliomas diagnosed at a single neurooncology center in China during 2000 to 2020. Sci Rep. 2025;15:12574. doi:10.1038/s41598-025-95693-5

[2] Jiang T, Nam DH, Ram Z, et al. Updated clinical practice guidelines for the management of adult diffuse gliomas. Cancer Lett. 2026 Mar 1;640:218185. doi: 10.1016/j.canlet.2025.218185.

[3] https://www.brainmed.com/info/detail?id=49249

[4] Chen W, Wang Y, Zhao B, et al. Optimal Therapies for Recurrent Glioblastoma: A Bayesian Network Meta-Analysis. Front Oncol. 2021 Mar 29;11:641878. doi: 10.3389/fonc.2021.641878.

For more information, please contact:

clinicaltrials@juncell.com