Actively Recruiting
Dual-Targeting CAR-NK Cells for Recurrent/Progressive Glioblastoma and High-Grade Glioma
Led by Beijing Biotech · Updated on 2026-03-18
36
Participants Needed
1
Research Sites
110 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 tumor resection or stereotactic biopsy, or availability of archived tumor tissue, for antigen testing and catheter placement.
- Tumor expresses at least two of these antigens above thresholds: IL13R2, EGFR (wild-type) and/or EGFRvIII, B7-H3 (CD276).
- Karnofsky Performance Status of 60 or higher.
- Adequate blood, kidney, and liver function per protocol tests.
- Ability to undergo brain MRI with contrast unless contraindicated.
- Negative pregnancy test for women who can become pregnant and agreement to use effective contraception during and after the study.
- Ability to understand and sign informed consent.
You will not qualify if you...
- Active uncontrolled infection including bacterial, viral, or fungal.
- Known HIV with uncontrolled viral load; active hepatitis B or C with detectable virus unless allowed.
- Autoimmune disease needing systemic immunosuppression within past 6 months.
- Need for high-dose systemic corticosteroids (>4 mg/day dexamethasone equivalent) within 7 days before lymphodepletion or infusion.
- Prior gene-modified cell therapy within 6 months or prior therapy targeting IL13R2, EGFR/EGFRvIII, or B7-H3 with residual engineered cells.
- Diffuse leptomeningeal disease only or anatomy preventing safe catheter placement unless allowed.
- Uncontrolled seizures despite optimal treatment.
- Significant cardiovascular disease increasing risk with lymphodepletion or infusion.
- Pregnant or breastfeeding.
- Any condition that may make participation unsafe or interfere with protocol adherence as judged by the investigator.
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
Seni 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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