Actively Recruiting
NK Cell Therapy for Malignant Solid Brain Tumors
Led by Peking University Third Hospital · Updated on 2026-04-27
27
Participants Needed
4
Research Sites
247 weeks
Total Duration
On this page
Sponsors
P
Peking University Third Hospital
Lead Sponsor
H
Henan Academy of Innovations in Medical Science
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
NK Cell Therapy for Malignant Solid Brain Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age 18-70 years old (both ends included)
- At least one evaluable lesion with biopsy or pathohistologic confirmation of malignant central nervous system tumor with imaging showing progression or recurrence after comprehensive treatment
- Karnofsky Performance Status (KPS) of 60% or higher
- Life expectancy greater than 4 weeks and able to undergo MRI with contrast
- Completed radiotherapy or systemic therapies at least 4 weeks prior to enrollment with treatment-related toxicities at grade 1 or less (except alopecia or leukoplakia)
- Dexamethasone dose of 4 mg/day or less or no dexamethasone
- Adequate organ and marrow function as specified (WBC ≥ 3 x 10^9/L; ANC > 1 x 10^9/L; Hemoglobin ≥ 90 g/L; Platelet ≥ 80 x 10^9/L; ALT & AST <1.5 x institutional upper limit; Serum creatinine <1.5 x institutional upper limit; Total bilirubin <1.5 x institutional upper limit; PT & PTT ≤ 1.25 x institutional upper limit)
- No obvious hereditary diseases
- Normal cardiac function with left ventricular ejection fraction >55%
- No bleeding or coagulation disorders
- Negative blood cultures for bacteria, fungus, or virus within 48 hours prior to NK cell infusion with no signs of meningitis
- Fertile women must have a negative pregnancy test within 7 days before treatment and agree to use contraception during the trial and for 6 months after last infusion
- Signed, written informed consent
You will not qualify if you...
- Active hepatitis B or C virus, HIV infection, or other untreated active infection
- Pregnant or lactating women
- Organ failure
- Chronic disease requiring immunologic or hormonal therapy
- Allergy to immunotherapy or related cells
- Uncontrolled intercurrent illness
- Psychiatric illness or social situations limiting compliance
- History of organ transplantation or awaiting organ transplantation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
2
Qinhuangdao Runze Hospital
Qinhuangdao, Hebei, China, 066607
Not Yet Recruiting
3
Zhengzhou Second Hospital
Zhengzhou, Henan, China, 450052
Actively Recruiting
4
Henan Academy of Innovations in Medical Science
Zhengzhou, Henan, China, 451162
Actively Recruiting
Research Team
C
Chenlong YANG, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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