Malignant Solid Brain TumorsNCT07552233
NK Cell Therapy for Malignant Solid Brain Tumors
A study testing Autologous NK cells in people with Malignant Solid Brain Tumors and Glioblastoma (GBM), run by Peking University Third Hospital at 4 sites in China.
Trial summary
This is a multi-center, open-label investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, and feasibility of combined intracranial and intravenous administration of ex vivo expanded and activated natural killer (NK) cells in adult patients with malignant solid brain tumors who have failed… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malignant Solid Brain Tumors, Glioblastoma (GBM), Glioblastoma Multiforme (GBM)
- What is being tested?
- Autologous NK cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesChina
- Study dates
- Apr 2026to 31 Dec 2030
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18-70 years old (both ends included)
- At least one evaluable lesion with previous biopsy or pathohistologic confirmation of malignant central nervous system tumor, with imaging suggestive of continued progression or recurrence after comprehensive treatment
- Karnofsky Performance Status (KPS) ≥ 60%
- Life expectancy > 4 weeks, and must be able to undergo an MRI with contrast
- Patients who completed radiotherapy or systemic therapies (including temozolomide/bevacizumab or other agents) for at least 4 weeks prior to enrollment. All prior treatment-related toxicities should be defined as ≤ grade 1 (except for toxicities such as alopecia or leukoplakia) according to the Common Terminology Standard for Adverse Events (CTCAE 6.0)
- Dexamethasone dose ≤ 4 mg/day or equivalent corticosteroid dose, or no dexamethasone administered
Show all 21Show fewer
- Must have adequate organ and marrow function as defined below:
- White blood cell count (WBC) ≥ 3 x 10^9/L
- Absolute neutrophil count (ANC) > 1 x 10^9/L
- Hemoglobin (Hb) ≥ 90 g/L
- Platelet (PLT) ≥ 80×10^9/L
- Albumin transaminase (ALT) \& albumin transaminase (AST) < 1.5 × institutional upper limit of normal (ULN)
- Serum creatinine (Cr) < 1.5 x institutional ULN
- Total bilirubin < 1.5 x institutional ULN
- PT \& PTT ≤ 1.25 x institutional ULN
- No obvious hereditary diseases
- Normal cardiac function with left ventricular ejection fraction >55%
- No bleeding and coagulation disorders
- Absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to NK cell infusion and/or there aren't any indications of meningitis
- Fertile women must have had a pregnancy test with a negative result within 7 days prior to the start of treatment, and subjects are willing to use contraception (hormonal or barrier method of birth control or abstinence) during the clinical trial and for 6 months after the last cell infusion; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- Signed, written informed consent
Who cannot join
- Active hepatitis B or C virus, HIV infection, or other untreated active infection
- Pregnant and lactating women
- Participants with organ failure
- Participants with a chronic disease requiring immunologic or hormonal therapy
- Participants with an allergy to immunotherapy and related cells
- Participants with uncontrolled intercurrent illness
- Participants with psychiatric illness/social situations that would limit compliance with study requirements
- Participants with a history of organ transplantation or who are awaiting organ transplantation
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Chenlong YANG, M.D., Ph.D., (+86)-135-1108-7060, vik.yang@pku.edu.cn
- Not yet recruiting
Qinhuangdao Runze Hospital
Qinhuangdao, Hebei, 066607
Chenlong YANG, M.D., Ph.D., (+86)-135-1108-7060, vik.yang@pku.edu.cn
- Recruiting
Zhengzhou Second Hospital
Zhengzhou, Henan, 450052
Chenlong YANG, M.D., Ph.D., (+86)-135-1108-7060, vik.yang@pku.edu.cn
- Recruiting
Henan Academy of Innovations in Medical Science
Zhengzhou, Henan, 451162
Chenlong YANG, M.D., Ph.D., (+86)-135-1108-7060, vik.yang@pku.edu.cn
About this study
Official title: NK Cell Therapy for the Treatment of Malignant Solid Brain Tumors
This is a multi-center, open-label investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, and feasibility of combined intracranial and intravenous administration of ex vivo expanded and activated natural killer (NK) cells in adult patients with malignant solid brain tumors who have failed standard treatment modalities. The primary objective is to determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of the combined NK cell therapy. Secondary objectives include preliminary assessment of anti-tumor activity as measured by progression-free survival (PFS), overall survival (OS), objective response rate (ORR) per RANO criteria, and evaluation of the immunological effects of NK cell infusion in the tumor microenvironment and peripheral blood.
- Conditions
- Malignant Solid Brain Tumors, Glioblastoma (GBM), Glioblastoma Multiforme (GBM), Brain Metastasis, Malignant Meningioma
- Being tested
- Autologous NK cells
- Keywords
- Malignant Solid Brain Tumors, Immunotherapy, Natural Killer Cell, NK Cell
- Medical subject headings
- Glioblastoma, Brain Neoplasms, Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous NK cellsDrug
Intrathecal Administration Combined with Intravenous Infusion of Autologous NK Cells
- Intracranial/Intrathecal Injection: NK cells are administered into the cerebrospinal fluid via a surgically implanted intracranial Ommaya reservoir or lumbar puncture. This approach successfully bypasses the blood-brain barrier, allowing NK cells to act directly on tumor lesions in the central nervous system.
- Intravenous Infusion:
Following intracranial/intrathecal injection, the patient receives an intravenous infusion of NK cells.
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Intracranial/Intrathecal Injection: 1x10^8 NK cells, every 2 weeks Intravenous Infusion: 2x10^8 NK cells, every 2 weeks Receives: Drug: Autologous NK cells |
| Medium dose | Experimental | Intracranial/Intrathecal Injection: 1x10^8 NK cells, every 2 weeks Intravenous Infusion: 9x10^8 NK cells, every 2 weeks Receives: Drug: Autologous NK cells |
| High dose | Experimental | Intracranial/Intrathecal Injection: 1x10^8 NK cells, every 2 weeks Intravenous Infusion: 2.9x10^9 NK cells, every 2 weeks Receives: Drug: Autologous NK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Defined as the incidence of ≥ Grade 3-4 adverse events related to NK cells according to common terminology criteria for adverse events (CTCAE) v6.0.
Measured: 3 months following NK cells administration
Incidence of Dose-Limiting Toxicities (DLTs)
Defined as events attributable to NK cells infusion within 28 days post-infusion. Grade 3 or higher cytokine release syndrome (CRS) lasting more than 2 weeks, according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria; Any NK cells-related AE requiring intubation; Grade 4 non-hematologic toxicities.
Measured: 28 days following initial treatment with NK cells
Secondary outcomes (2)
Objective Response Rate (ORR)
According to modified RANO criteria, ORR is defined as proportion of subjects with confirmed CR and PR.
Measured: 3 months following NK cells administration
Duration of response (DOR)
According to modified RANO criteria, DOR is defined as time from the date when a response of confirmed CR/PR is first met to the date of confirmed disease progression or death.
Measured: 3 months following NK cells administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid Brain TumorsStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- 3+3 Dose escalation design
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Academy of Innovations in Medical Science, Zhengzhou Second Hospital, Qinhuangdao Runze Hospital
- Responsible party
- Principal investigator, Chenlong YANG, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552233
- Sponsor's protocol ID
- 20230484356
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NK Cell Therapy for the Treatment of Malignant Solid Brain Tumors
- ClinicalTrials.gov ID
- NCT07552233
- Acronym / sponsor ID
- 20230484356
- Conditions
- Malignant Solid Brain Tumors, Glioblastoma (GBM), Glioblastoma Multiforme (GBM), Brain Metastasis, Malignant Meningioma
- Keywords
- Malignant Solid Brain Tumors, Immunotherapy, Natural Killer Cell, NK Cell
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Henan Academy of Innovations in Medical Science, Zhengzhou Second Hospital, Qinhuangdao Runze Hospital
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Apr 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 is a multi-center, open-label investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, and feasibility of combined intracranial and intravenous administration of ex vivo expanded and activated natural killer (NK) cells in adult patients with malignant solid brain tumors who have failed standard treatment modalities. The primary objective is to determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of the combined NK cell therapy. Secondary objectives include preliminary assessment of anti-tumor activity as measured by progression-free survival (PFS), overall survival (OS), objective response rate (ORR) per RANO criteria, and evaluation of the immunological effects of NK cell infusion in the tumor microenvironment and peripheral blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3+3 Dose escalation design
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: Autologous NK cellsIntracranial/Intrathecal Injection: 1x10^8 NK cells, every 2 weeks Intravenous Infusion: 2x10^8 NK cells, every 2 weeks |
| Medium dose | Experimental | Drug: Autologous NK cellsIntracranial/Intrathecal Injection: 1x10^8 NK cells, every 2 weeks Intravenous Infusion: 9x10^8 NK cells, every 2 weeks |
| High dose | Experimental | Drug: Autologous NK cellsIntracranial/Intrathecal Injection: 1x10^8 NK cells, every 2 weeks Intravenous Infusion: 2.9x10^9 NK cells, every 2 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male or female, age 18-70 years old (both ends included)
- At least one evaluable lesion with previous biopsy or pathohistologic confirmation of malignant central nervous system tumor, with imaging suggestive of continued progression or recurrence after comprehensive treatment
- Karnofsky Performance Status (KPS) ≥ 60%
- Life expectancy > 4 weeks, and must be able to undergo an MRI with contrast
- Patients who completed radiotherapy or systemic therapies (including temozolomide/bevacizumab or other agents) for at least 4 weeks prior to enrollment. All prior treatment-related toxicities should be defined as ≤ grade 1 (except for toxicities such as alopecia or leukoplakia) according to the Common Terminology Standard for Adverse Events (CTCAE 6.0)
Key exclusion criteria (8 listed)
- Active hepatitis B or C virus, HIV infection, or other untreated active infection
- Pregnant and lactating women
- Participants with organ failure
- Participants with a chronic disease requiring immunologic or hormonal therapy
- Participants with an allergy to immunotherapy and related cells
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 |
|---|---|---|
| Autologous NK cellsIntrathecal Administration Combined with Intravenous Infusion of Autologous NK Cells 1. Intracranial/Intrathecal Injection: NK cells are administered into the cerebrospinal fluid via a surgically implanted intracranial Ommaya reservoir or lumbar puncture. This approach successfully bypasses the blood-brain barrier, allowing NK cells to act directly on tumor lesions in the central nervous system. 2. Intravenous Infusion: Following intracranial/intrathecal injection, the patient receives an intravenous infusion of NK cells. | Drug | High dose, Low dose, Medium dose |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: 3 months following NK cells administration
Defined as the incidence of ≥ Grade 3-4 adverse events related to NK cells according to common terminology criteria for adverse events (CTCAE) v6.0.
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: 28 days following initial treatment with NK cells
Defined as events attributable to NK cells infusion within 28 days post-infusion. Grade 3 or higher cytokine release syndrome (CRS) lasting more than 2 weeks, according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria; Any NK cells-related AE requiring intubation; Grade 4 non-hematologic toxicities.
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: 3 months following NK cells administration
Duration of response (DOR)
Time frame: 3 months following NK cells administration
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 27 Apr 2026.
Related trials for Malignant Solid Brain Tumors
Active, not recruitingPhase 1
Ropidoxuridine and Whole Brain Radiation Therapy in Treating Patients With Brain Metastases
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1/2
Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
Non Small Cell Lung Cancer, Glioma Glioblastoma Multiforme
Active, not recruitingPhase 1
Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
Anal Carcinoma, Bladder Carcinoma
Recruiting
Magnetic Resonance (MR) Imaging to Determine High Risk Areas in Patients With Malignant Gliomas and to Design Potential Radiation Plans and to Examine Metabolite Changes in Gliomas and Other Solid Tumors
Brain Cancer, Glioma
RecruitingEarly Phase 1
Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases
Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous NK cells in people with Malignant Solid Brain Tumors and Glioblastoma (GBM), run by Peking University Third Hospital at 4 sites in China.
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 21 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 Apr 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 China. 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 Chenlong YANG, M.D., Ph.D. ((+86)-135-1108-7060, vik.yang@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: 3 months following NK cells administration). The study lists 2 primary outcomes in all. 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 27 Apr 2026.