Can a Patient's own immune cells fight back against recurrent brain cancer?
NCT ID NCT07831161
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing CHANK-101, a therapy made from a patient's own natural killer (NK) cells, in adults with glioblastoma that has returned after standard treatment. The study enrolls 60 participants who receive intravenous infusions of these cells every two weeks for up to 12 doses. The main goal is to measure how long participants live without their cancer getting worse, while also tracking side effects and overall survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an autologous natural killer (NK) cell therapy called CHANK-101, made from the patient's own blood cells
- What this could lead to
- If it works, this could offer a new treatment option for people whose glioblastoma has returned after standard therapy, a group with few effective choices.
- What could go wrong
- This is an early-stage, open-label study with no randomization and only 60 participants, so results may not hold up in larger trials. Cell therapies can also cause immune reactions or other serious side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 69 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 2. Histologically confirmed IDH-wildtype glioblastoma (GBM), WHO Grade 4, according to the WHO CNS5 2021 classification. 3. Completion of standard first-line treatment (surgery + radiotherapy + concurrent TMZ → 6 cycles of adjuvant TMZ). 4. 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. 5\. No antitumor treatment, including chemotherapy, immunotherapy, targeted therapy, or radiotherapy, after confirmation of recurrence, except surgery. 6\. KPS ≥ 60. 7\. Adequate organ function permitting study treatment and surgery, including: 1. Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L. 2. Platelets ≥ 100 × 10\^9/L. 3. Hemoglobin (Hb) ≥ 9.0 g/dL. 4. AST and ALT ≤ 2.5 × ULN. 5. Total bilirubin ≤ 1.5 × ULN. 6. Serum creatinine ≤ 1.5 × ULN or eGFR ≥ 50 mL/min/1.73 m\^2. 8\. Adequate peripheral venous access for leukapheresis or ability to undergo central venous catheter placement. 9\. Life expectancy of at least 12 weeks, as determined by the investigator. 10\. Female participants who are postmenopausal, defined as 12 months of amenorrhea without a medical cause, or women of childbearing potential with a negative pregnancy test. 11\. Women of childbearing potential and male participants who agree to use appropriate contraception (e.g., condoms, hormonal contraceptives, oral contraceptives, intrauterine devices, or sterilization) during the study and for 3 months after the last administration of the study treatment. Exclusion Criteria: 1. Two or more recurrences or prior antitumor treatment for a previous recurrence. 2. Confirmed leptomeningeal dissemination or extracranial metastasis. 3. 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. 4. 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. 5. 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. 6\. Uncontrolled active infection or any other infectious disease considered by the investigator to be inappropriate for participation in the study. 7\. 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. 8\. Contraindication to leukapheresis (e.g., severe cardiovascular disease or coagulation disorder). 9\. Serious medical or psychiatric condition that may affect participation in the study. 10\. History of a severe allergic reaction or other serious hypersensitivity to the study treatment or any of its excipients. 11\. Pregnant or breastfeeding women. 12\. Participants planning pregnancy during the study. 13\. Participants considered by the investigator unlikely to comply with study treatment, study procedures, or follow-up. 14\. Any other participant considered by the investigator to be unsuitable for participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asan Medical Center
Seoul, Seoul, 05505, South Korea
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CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496, South Korea
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Dong-A University Hospital
Busan, Busan, 49201, South Korea
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Gangnam Severance Hospital
Seoul, Seoul, 06273, South Korea
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