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

Sponsor
Beijing Biotech
Study ID
NCT07480941
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dual-target CAR-NK cells — BIOLOGICAL
    Dual-target CAR-NK cells
  • Cyclophosphamide — DRUG
    Cyclophosphamide
  • Fludarabine — DRUG
    Fludarabine
  • Intracranial catheter/reservoir for locoregional delivery — DEVICE
    Intracranial catheter/reservoir for locoregional delivery

Study Details

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.

Key Dates

First listed
Mar 18, 2026
Start date
Feb 2, 2026
Status verified
Mar 2026
Primary completion
Feb 18, 2027
Completion
Mar 17, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: IL13Rα2 + EGFR/EGFRvIII Dual-Target CAR-NK
    Participants whose tumors meet eligibility thresholds for IL13Rα2 and EGFR (and/or EGFRvIII) will receive a dual-target (tandem) CAR-NK product recognizing IL13Rα2 and EGFR/EGFRvIII.
  • Experimental: IL13Rα2 + B7-H3 (CD276) Dual-Target CAR-NK
    Participants whose tumors meet eligibility thresholds for IL13Rα2 and B7-H3 (CD276) will receive a dual-target (tandem) CAR-NK product recognizing IL13Rα2 and B7-H3.
  • Experimental: EGFR/EGFRvIII + B7-H3 (CD276) Dual-Target CAR-NK
    Participants whose tumors meet eligibility thresholds for EGFR (and/or EGFRvIII) and B7-H3 (CD276) will receive a dual-target (tandem) CAR-NK product recognizing EGFR/EGFRvIII and B7-H3.

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 28 Days ]

Central Contacts

Find similar trials

Nationwide
Brain cancer trialsOncology trialsNeuro-oncology trials

Related Studies