Actively Recruiting
NK Cell Therapy for the Treatment of Malignant Solid Brain Tumors
Led by Peking University Third Hospital · Updated on 2026-04-27
27
Participants Needed
4
Research Sites
4 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
Researchers are evaluating the safety, tolerability, and feasibility of a combined natural killer (NK) cell therapy administered both inside the brain and through the bloodstream in adults with malignant solid brain tumors who have not responded to standard treatments. This trial aims primarily to find the highest safe dose of this combined NK cell therapy. Secondary goals include early assessments of its anti-tumor effects using measures like progression-free survival, overall survival, and tumor response, along with studying immune changes in the tumor and blood. Participants receive NK cell therapy through intracranial or intrathecal injections using a surgically implanted reservoir or lumbar puncture, combined with intravenous infusions. There are three dosing groups: low, medium, and high dose, each receiving intracranial injections of 100 million NK cells every two weeks paired with increasing intravenous doses every two weeks. This open-label trial is randomized and conducted at multiple centers. During the study, participants will be closely monitored for adverse events and dose-limiting toxicities up to three months after treatment. Researchers will assess tumor response and duration of response at three months post-treatment. Participants must have regular MRI scans with contrast and laboratory tests to evaluate organ function and immune response. The total participation period includes treatment and follow-up assessments to evaluate safety and preliminary effectiveness of the therapy.
CONDITIONS
Brief 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 ongoing progression or recurrence after 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, with prior treatment toxicities at grade 1 or less (except alopecia or leukoplakia)
- Dexamethasone dose 4 mg/day or less, or no corticosteroids
- Adequate organ and marrow function as defined by blood counts and liver/kidney function within specified limits
- No obvious hereditary diseases
- Normal cardiac function with left ventricular ejection fraction above 55%
- No bleeding or coagulation disorders
- No positive blood cultures or signs of meningitis within 48 hours before NK infusion
- Fertile women must have negative pregnancy test within 7 days before treatment and agree to contraception during trial and 6 months after
- Signed informed consent
You will not qualify if you...
- Active hepatitis B or C virus, HIV infection, or other untreated active infections
- Pregnant or lactating women
- Organ failure
- Chronic diseases requiring immunologic or hormonal therapy
- Allergy to immunotherapy or related cells
- Uncontrolled intercurrent illness
- Psychiatric illness or social situations limiting study compliance
- History of organ transplantation or awaiting transplant
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 2-week cycles
Participants receive NK cell therapy through intracranial/intrathecal injections via a surgically implanted Ommaya reservoir or lumbar puncture, combined with intravenous infusions of autologous NK cells every 2 weeks.
Visits every 2 weeks for NK cell administration
Duration - Up to 3 months following treatment
Participants are monitored for adverse events, dose-limiting toxicities, and treatment response for up to 3 months following NK cell administration.
Visits as needed for safety and response assessments
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.
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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