Recurrent GlioblastomaNCT07831161
Safety and Efficacy of Autologous Natural Killer Cell Therapy (CHANK-101) in Patients With Recurrent Glioblastoma
A study testing CHANK-101 in people with Recurrent Glioblastoma, run by Dong-A University Hospital at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- CHANK-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 29 Nov 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Progressive Disease according to RANO 2.0 criteria on MRI more than 12 weeks after completion of radiotherapy.
- 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.
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- 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:
- 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.
- 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.
Who cannot join
- 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:
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites
Dong-A University Hospital
Busan, Busan, 49201
Kyoungsu Sung, MD, 82-51-240-5241, sungks1465@gmail.com
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496
Jaejoon Lim, MD, PhD, 82-31-780-5688, coolppeng@chamc.co.kr
Asan Medical Center
Seoul, Seoul, 05505
ChangKi Hong, MD, PhD, 82-2-3010-3550, changki.hong@amc.seoul.kr
Gangnam Severance Hospital
Seoul, Seoul, 06273
Jihwan Yoo, MD, 82-2-2019-2480, JHY8486@yuhs.ac
About this study
Official title: A Multicenter, Open-label, Externally Controlled Clinical Study to Evaluate the Safety and Efficacy of Autologous Natural Killer Cell (CHANK-101) in Patients With Recurrent Glioblastoma
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).
Read the detailed description
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.
- Conditions
- Recurrent Glioblastoma
- Being tested
- CHANK-101
- Keywords
- Recurrent Glioblastoma, Autologous Natural Killer Cells, CHANK-101, NK Cell Terapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHANK-101Biological
Also called Autologous Natural Killer Cell Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: CHANK-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: From the first administration of CHANK-101 until death from any cause, assessed up to Week 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start29 Nov 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KYOUNGSU SUNG, Dong-A University Hospital
- Investigators
- Kyoungsu Sung, MD, Principal investigator, Dong-A University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831161
- Sponsor's protocol ID
- CHANK-101
- Other IDs
- KCT0012590
- Status last verified
- Oct 2026
- First submitted
- 7 Sep 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Externally Controlled Clinical Study to Evaluate the Safety and Efficacy of Autologous Natural Killer Cell (CHANK-101) in Patients With Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT07831161
- Acronym / sponsor ID
- CHANK-101
- Conditions
- Recurrent Glioblastoma
- Keywords
- Recurrent Glioblastoma, Autologous Natural Killer Cells, CHANK-101, NK Cell Terapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dong-A University HospitalUniversity, hospital or other
- Study start
- 29 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHANK-101 Treatment Group | Experimental | Biological: CHANK-101Participants 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. |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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:
- Progressive Disease according to RANO 2.0 criteria on MRI more than 12 weeks after completion of radiotherapy.
Key exclusion criteria (15 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHANK-101Also: Autologous Natural Killer Cell TherapyCHANK-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. | Biological | CHANK-101 Treatment Group |
Primary outcome
Progression-Free Survival (PFS)
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.
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.
3 secondary outcomes
Number of Participants With Adverse Events as Assessed by NCI-CTCAE Version 5.0
Time frame: From the first administration of CHANK-101 through Week 48.
Progression-Free Survival at 6 Months (PFS-6)
Time frame: 6 months after the first administration of CHANK-101
Overall Survival (OS)
Time frame: From the first administration of CHANK-101 until death from any cause, assessed up to Week 48.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyoungsu Sung, MD principal investigator
Dong-A University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHANK-101 in people with Recurrent Glioblastoma, run by Dong-A University Hospital at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyoungsu Sung, MD (82-51-240-5241, sungks1465@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.