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).
This is a multicenter, open-label, externally controlled exploratory clinical study evaluating the safety and efficacy of CHANK-101, an autologous natural killer (NK) cell therapy, in patients with recurrent glioblastoma. The study is intended to assess the feasibility and safety of CHANK-101 administration and to explore signals of clinical efficacy to inform the design of future confirmatory studies. Eligible participants will undergo leukapheresis for the collection of peripheral blood cells used for the manufacture of CHANK-101. The first intravenous administration of CHANK-101 will begin 4 to 6 weeks after leukapheresis. For participants scheduled to undergo surgical resection of the recurrent lesion, leukapheresis will be performed within 2 weeks before surgery, and the first administration of CHANK-101 will begin 4 to 6 weeks after surgery. CHANK-101 will subsequently be administered intravenously every 2 weeks for up to 12 administrations. The primary efficacy endpoint is progression-free survival (PFS), assessed according to the Response Assessment in Neuro-Oncology (RANO) 2.0 criteria. Secondary evaluations include the safety and tolerability of CHANK-101, progression-free survival at 6 months (PFS-6), and overall survival (OS). Because of the challenges associated with establishing a randomized control group in this patient population, clinical outcomes in participants receiving CHANK-101 will be compared with those of an external control group. The external control group will consist of patients from the same participating institutions and will be evaluated using the same eligibility criteria and assessment criteria as the CHANK-101 treatment group.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
CHANK-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.
Dong-A University Hospital
Busan, Busan, South Korea
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Asan Medical Center
Seoul, Seoul, South Korea
Gangnam Severance Hospital
Seoul, Seoul, South Korea
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.
Time frame: From the first administration of CHANK-101 until disease progression or death from any cause, whichever occurs first, assessed up to Week 48.
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.
Time frame: From the first administration of CHANK-101 through Week 48.
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.
Time frame: 6 months after the first administration of CHANK-101
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.
Time frame: From the first administration of CHANK-101 until death from any cause, assessed up to Week 48.
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NONE
Enrollment
60