RecruitingPhase 1NCT07480941

Dual-Targeting CAR-NK Cells for Recurrent/Progressive Glioblastoma and High-Grade Glioma

A Phase 1, First-in-Human, Biomarker-Guided, Dose-Escalation and Expansion Study of Locoregional Dual-Targeting CAR-NK Cells Directed Against IL13Rα2, EGFR/EGFRvIII, and/or B7-H3 (CD276) in Adults With Recurrent or Progressive Glioblastoma or High-Grade Glioma


Sponsor

Beijing Biotech

Enrollment

36 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment for recurrent or growing brain tumors (glioblastoma and other high-grade gliomas) using engineered immune cells called CAR-NK cells. These cells are designed to seek out and destroy brain cancer cells by targeting specific proteins the tumors carry. This is an early-phase study focused on safety and early effectiveness. **You may be eligible if...** - You are aged 18–75 and have a confirmed high-grade brain tumor (grade 3 or 4) that has come back or continued growing after standard treatment - Your tumor expresses at least two specific proteins targeted by the therapy (IL13Rα2, EGFR, or B7-H3) - You are functional enough to carry out daily activities (KPS ≥ 60) - You are able to have a brain MRI - You have adequate blood, kidney, and liver function **You may NOT be eligible if...** - You have an active uncontrolled infection, or uncontrolled HIV, hepatitis B, or hepatitis C - You have a significant autoimmune disease requiring immune-suppressing drugs - You are on high-dose steroids - You received a similar gene-modified cell therapy within the past 6 months - You have uncontrolled seizures - You have had a recent heart attack or serious heart condition - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDual-target CAR-NK cells

Dual-target CAR-NK cells

DRUGCyclophosphamide

Cyclophosphamide

DRUGFludarabine

Fludarabine

DEVICEIntracranial catheter/reservoir for locoregional delivery

Intracranial catheter/reservoir for locoregional delivery


Locations(1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

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NCT07480941


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