ClinicalTrials.gg
Not yet recruitingNCT07831161Updated Nov 2, 2026

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

An interventional study of CHANK-101 in Recurrent Glioblastoma, sponsored by Dong-A University Hospital. Not yet recruiting at 4 sites in South Korea. Open to participants aged 19 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Dong-A University Hospital · Not applicable, Interventional, and Treatment

Updated Nov 2, 2026Start date movedGo to Updates ↓

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
19 Years to 69 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 39 studies in Glioblastoma with a site in Korea, Republic of — 8 open to participants now, 13 under way, 2 of them phase 3. Glioblastoma · Korea, Republic of.

Planned enrollment
20th of 35
60 · median 81
Started
2026
the only one that year
No phase
3 of 39
2 open now
Primary completion
2027-11
later than 9 of 12 live
Registered
39th of 39
by date

Among the 39 studies in Glioblastoma with a site in Korea, Republic of, this one is the 20th largest by planned enrollment of the 35 interventional ones that give a count, is the only one that started in 2026, is one of 3 with no phase, reaches primary completion later than 9 of the 12 other live ones, and was the 39th registered.

Glioblastoma

2,134 studies on the registry are indexed under Glioblastoma; 466 are open to participants now.

Browse Glioblastoma studies →

Open to participants now

8 of the 39 studies in Glioblastoma with a site in Korea, Republic of are open now. Recruiting first, the newest first:

2 more — sign in →

All 8 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 339 Glioblastoma studies recruiting now, 234 (69%) set no upper age limit and 65 (19%) stop at 75 or younger; 27 take children under 18; 13 take healthy volunteers.

This study: 19 Years to 69 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 39 studies in Glioblastoma with a site in Korea, Republic of, or all of them as a file.
02

Study 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).

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.

03

Conditions studied

  • Recurrent Glioblastoma

Browse trials for

Keywords

  • Recurrent Glioblastoma
  • Autologous Natural Killer Cells
  • CHANK-101
  • NK Cell Terapy
04

Who can participate

Ages eligible
19 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  2. confirmed IDH-wildtype glioblastoma (GBM), WHO Grade 4, according to the WHO CNS5 2021 classification.
  3. Completion of standard 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. ≥ 60.

7. Adequate organ function permitting study treatment and surgery, including:

  1. (ANC) ≥ 1.5 × 10\^9/L.
  2. ≥ 100 × 10\^9/L.
  3. (Hb) ≥ 9.0 g/dL.
  4. and ALT ≤ 2.5 × .
  5. Total ≤ 1.5 × ULN.
  6. Serum creatinine ≤ 1.5 × ULN or ≥ 50 mL/min/1.73 m\^2.

8. Adequate peripheral venous access for leukapheresis or ability to undergo central venous catheter placement.

9. of at least 12 weeks, as determined by the investigator.

10. Female participants who are , defined as 12 months of amenorrhea without a medical cause, or women of with a negative pregnancy test.

11. Women of childbearing potential and male participants who agree to use appropriate (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

Exclusion Criteria:

  1. Two or more recurrences or prior antitumor treatment for a previous recurrence.
  2. Confirmed dissemination or extracranial .
  3. Requirement for chronic high-dose systemic (e.g., >10 mg/day prednisolone equivalent) or continuous use of other drugs. Low-dose corticosteroid use at enrollment is permitted; however, the criteria must be met at each study treatment administration.
  4. Active 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 impact on participation in the study:

(1) /HBV NAT. (2) Ab/HCV NAT. (3) 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 within the past 3 years, except adequately treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.

8. 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 to the study treatment or any of its .

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.

Terms in these criteria, in plain language(29)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    CHANK-101 Treatment Group

    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

  • BiologicalCHANK-101

    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

06

What researchers measure

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.

    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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

07

Study locations

4 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.

Of 131 non-industry interventional studies with no phase under Glioblastoma, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 97. This study's planned 12 months is below that.

Counting every sponsor, half of 149 studies reached it within 54 months; a quarter within 36 and three quarters within 88.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Nov 2, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2026
First posted
Sep 21, 2026
StartEst.
Nov 29, 2026was Sep 2026
Primary completionEst.
Nov 30, 2027
CompletionEst.
Mar 31, 2028
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 29, 2026→Nov 29, 2026
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Start date Sep 29, 2026→Nov 29, 2026
    + 2 other changes: identifiers and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07831161
Lead sponsor
Dong-A University Hospital
Responsible party
KYOUNGSU SUNG (Associate Professor, Dong-A University Hospital) — Principal investigator
First posted
Sep 21, 2026
Start date
Nov 29, 2026 (estimated)
Primary completion
Nov 30, 2027 (estimated)
Completion
Mar 31, 2028 (estimated)
Last update
Nov 2, 2026

Study contacts

Kyoungsu Sung, MD
Contact
sungks1465@gmail.com
82-51-240-5241
Kyoungsu Sung, MD
principal investigator · Dong-A University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion