NK Cell Therapy for Malignant Solid Brain Tumors

Recruiting now · Not applicable

Conditions studied: Malignant Solid Brain Tumors, Glioblastoma (GBM), Glioblastoma Multiforme (GBM), Brain Metastasis, Malignant Meningioma

In brief

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.

Key facts

Study ID: NCT07552233
Run by: Peking University Third Hospital
People needed: 27
Starts: 2026-04-01
Expected to finish: 2030-12-31
Last updated by the study team: 2026-04-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
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

You may not qualify if…

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

Where it is running

Peking University Third Hospital — Beijing, Beijing Municipality, China (enrolling)
Zhengzhou Second Hospital — Zhengzhou, Henan, China (enrolling)
Henan Academy of Innovations in Medical Science — Zhengzhou, Henan, China (enrolling)
Qinhuangdao Runze Hospital — Qinhuangdao, Hebei, China

Full record on ClinicalTrials.gov

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