Actively Recruiting
Dual-Targeting CAR-NK Cells for Recurrent/Progressive Glioblastoma and High-Grade Glioma
Led by Beijing Biotech · Updated on 2026-04-24
36
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a draft, ClinicalTrials.gov-style example record for a first-in-human Phase 1 study evaluating locoregional administration of dual-targeting chimeric antigen receptor natural killer (CAR-NK) cells in adults with recurrent or progressive glioblastoma (GBM) or other high-grade glioma (HGG). Participants will undergo tumor antigen profiling for IL13Rα2, EGFR/EGFRvIII, and B7-H3 (CD276). Based on this assessment, each participant will receive the most suitable dual-target CAR construct to reduce antigen-escape risk.
CONDITIONS
Official Title
Dual-Targeting CAR-NK Cells for Recurrent/Progressive Glioblastoma and High-Grade Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at the time of consent.
- Histologically confirmed glioblastoma (WHO grade 4) or diffuse high-grade glioma (WHO grade 3 or 4) that is recurrent or progressive after standard therapy.
- Planned clinically indicated tumor resection or stereotactic biopsy (or availability of adequate archived tumor tissue) to support antigen testing and locoregional catheter placement.
- Tumor demonstrates expression of at least two of the following antigens above protocol-defined thresholds: IL13Rb12, EGFR (wild-type) and/or EGFRvIII, B7-H3 (CD276).
- Karnofsky Performance Status (KPS) 60.
- Adequate organ function (hematologic, renal, hepatic) as defined by protocol laboratory criteria.
- Ability to undergo brain MRI with contrast (unless contraindicated and alternative imaging is permitted).
- Negative pregnancy test for women of childbearing potential; agreement to use effective contraception during study participation and for a protocol-defined period after infusion.
- Ability to understand and willingness to sign informed consent.
You will not qualify if you...
- Active, uncontrolled infection (including uncontrolled bacterial, viral, or fungal infection).
- Known HIV infection with uncontrolled viral load; active hepatitis B or hepatitis C with detectable viral load (unless permitted per protocol).
- Clinically significant autoimmune disease requiring systemic immunosuppression within the past 6 months.
- Requirement for high-dose systemic corticosteroids (e.g., >4 mg/day dexamethasone equivalent) within 7 days prior to lymphodepletion/infusion (physiologic replacement permitted).
- Prior gene-modified cellular therapy (e.g., prior CAR-T/CAR-NK) within 6 months, or prior therapy targeting IL13Rb12, EGFR/EGFRvIII, or B7-H3 where residual engineered cells could confound safety assessments.
- Diffuse leptomeningeal disease as the only site of disease, or anatomy that precludes safe catheter placement (unless specifically allowed by protocol).
- Uncontrolled seizures despite optimal medical therapy.
- Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia) that would increase risk with lymphodepletion or infusion procedures.
- Pregnant or breastfeeding.
- Any condition that, in the investigator's judgment, would make the participant unsuitable for the study or could interfere with protocol adherence.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
shan S Lu, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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