This multicenter, open-label, externally controlled clinical study is designed to evaluate the safety and efficacy of CHANK-101, an autologous natural killer (NK) cell therapy, in patients with recurrent glioblastoma. The primary objective is to evaluate progression-free survival (PFS) following CHANK-101 administration. Secondary objectives include evaluating safety and tolerability, progression-free survival at 6 months (PFS-6), and overall survival (OS).
Male or female adults aged 19 years to less than 70 years who have received sufficient explanation regarding the purpose, methods, potential benefits, and risks of the study and have voluntarily provided written informed consent.
Histologically confirmed IDH-wildtype glioblastoma (GBM), WHO Grade 4, according to the WHO CNS5 2021 classification.
Completion of standard first-line treatment (surgery + radiotherapy + concurrent TMZ → 6 cycles of adjuvant TMZ).
Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L.
Two or more recurrences or prior antitumor treatment for a previous recurrence.
Confirmed leptomeningeal dissemination or extracranial metastasis.
Requirement for chronic high-dose systemic corticosteroids (e.g., >10 mg/day prednisolone equivalent) or continuous use of other immunosuppressive drugs. Low-dose corticosteroid use at enrollment is permitted; however, the washout criteria must be met at each study treatment administration.
Active autoimmune disease requiring systemic immunosuppressive treatment within the past 2 years (e.g., steroids ≥10 mg/day prednisolone equivalent or immunosuppressive agents). Exceptions include adequately treated Basedow/Graves disease or Hashimoto thyroiditis with stable thyroid hormone replacement therapy, vitiligo, resolved childhood asthma, type 1 diabetes, and localized skin disorders.
Single group
CHANK-101
Biological/VaccineCHANK-101 is an autologous natural killer (NK) cell therapy manufactured from peripheral blood cells collected by leukapheresis. CHANK-101 will be administered intravenously at a dose of 2-6 × 10\^9 cells every 2 weeks for up to 12 administrations.
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from the first administration of CHANK-101 to the first occurrence of disease progression according to RANO 2.0 criteria or death from any cause, whichever occurs first.
Number of Participants With Adverse Events as Assessed by NCI-CTCAE Version 5.0
Adverse events will be coded using MedDRA by System Organ Class (SOC) and Preferred Term (PT) and assessed for severity using NCI-CTCAE Version 5.0. The number of participants with adverse events will be summarized by type, severity, causality, action taken, outcome, and whether the event led to study discontinuation.
Progression-Free Survival at 6 Months (PFS-6)
PFS-6 is defined as the proportion of participants who are alive without disease progression at 6 months after the first administration of CHANK-101. Disease progression will be assessed according to RANO 2.0 criteria.
Overall Survival (OS)
Overall survival (OS) is defined as the time from the first administration of CHANK-101 to death from any cause. Participants who are alive at the end of the study will be censored at the date they were last known to be alive.
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