Safety and Efficacy of Autologous Natural Killer Cell Therapy (CHANK-101) in Patients With Recurrent Glioblastoma

NCT07831161 | Not Yet Recruiting

• 1 other identifier: CHANK-101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Recurrent Glioblastoma

Keywords

Recurrent Glioblastoma; Autologous Natural Killer Cells; CHANK-101; NK Cell Terapy

Outcome Measures

Primary Outcomes (1)

• 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.

  From the first administration of CHANK-101 until disease progression or death from any cause, whichever occurs first, assessed up to Week 48.

Secondary Outcomes (3)

• Number of Participants With Adverse Events as Assessed by NCI-CTCAE Version 5.0

  From the first administration of CHANK-101 through Week 48.

• Progression-Free Survival at 6 Months (PFS-6)

  6 months after the first administration of CHANK-101

• Overall Survival (OS)

  From the first administration of CHANK-101 until death from any cause, assessed up to Week 48.

Study Arms (1)

CHANK-101 Treatment Group

EXPERIMENTAL

Participants will receive CHANK-101, an autologous natural killer (NK) cell therapy, by intravenous administration. The first administration will begin 4 to 6 weeks after leukapheresis, or 4 to 6 weeks after surgery for participants undergoing surgical resection of the recurrent lesion. CHANK-101 will subsequently be administered every 2 weeks for up to 12 administrations.

Biological: CHANK-101

Interventions

CHANK-101 BIOLOGICAL

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.

Also known as: Autologous Natural Killer Cell Therapy

CHANK-101 Treatment Group

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Confirmed first recurrence, defined by at least one of the following:
• (1) Progressive Disease according to RANO 2.0 criteria on MRI more than 12 weeks after completion of radiotherapy.
• (2) If within 12 weeks after completion of radiotherapy, pseudoprogression has been excluded through the RANO 2.0 confirmation procedure (confirmatory scan), and persistent progression has been confirmed on two consecutive scans at least 4 weeks apart.
• \. No antitumor treatment, including chemotherapy, immunotherapy, targeted therapy, or radiotherapy, after confirmation of recurrence, except surgery.
• \. KPS ≥ 60.
• \. Adequate organ function permitting study treatment and surgery, including:
• Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L.
• Platelets ≥ 100 × 10\^9/L.
• Hemoglobin (Hb) ≥ 9.0 g/dL.
• AST and ALT ≤ 2.5 × ULN.
• Total bilirubin ≤ 1.5 × ULN.
• Serum creatinine ≤ 1.5 × ULN or eGFR ≥ 50 mL/min/1.73 m\^2.

You may not qualify if:

• 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.
• A positive result for any of the following infectious disease tests performed at screening. However, participants with a positive result may participate if the investigator determines that it has no clinically significant impact on participation in the study:
• (1) HBsAg/HBV NAT. (2) HCV Ab/HCV NAT. (3) HIV Ab/HIV NAT. (4) Syphilis (non-treponemal/treponemal). (5) HTLV Ab. (6) CMV Ab/CMV NAT.
• \. Uncontrolled active infection or any other infectious disease considered by the investigator to be inappropriate for participation in the study.
• \. History of another malignancy within the past 3 years, except adequately treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.
• \. Contraindication to leukapheresis (e.g., severe cardiovascular disease or coagulation disorder).
• \. Serious medical or psychiatric condition that may affect participation in the study.
• \. History of a severe allergic reaction or other serious hypersensitivity to the study treatment or any of its excipients.
• \. Pregnant or breastfeeding women.
• \. Participants planning pregnancy during the study.
• \. Participants considered by the investigator unlikely to comply with study treatment, study procedures, or follow-up.
• \. Any other participant considered by the investigator to be unsuitable for participation in the study.

Sponsors & Collaborators

• Dong-A University Hospital: lead

Study Sites (4)

Dong-A University Hospital

Busan, Busan, 49201, South Korea

Location

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Asan Medical Center

Seoul, Seoul, 05505, South Korea

Location

Gangnam Severance Hospital

Seoul, Seoul, 06273, South Korea

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Kyoungsu Sung, MD

  Dong-A University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyoungsu Sung, MD

CONTACT

82-51-240-5241; sungks1465@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 21, 2026
• Study Start: September 29, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)