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

Sponsor
Beijing Biotech
Study ID
NCT07551336
Phase
PHASE1
Status
Recruiting
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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 (IL13Rα2/EGFR/EGFRvIII construct): Allogeneic natural killer (NK) cells genetically engineered to express a chimeric antigen receptor (CAR) designed to recognize tumor-associated antigens including IL13Rα2, EGFR, and EGFRvIII. This multi-targeting strategy aims to enhance tumor recognition, reduce antigen escape, and improve cytotoxic activity against heterogeneous tumor cell populations. The engineered CAR-NK cells are administered via locoregional delivery (e.g., intracavitary or through an Ommaya reservoir) to achieve targeted anti-tumor effects while minimizing systemic toxicity.
  • Cyclophosphamide — DRUG
    An alkylating chemotherapy agent used as part of lymphodepleting conditioning prior to CAR-NK cell infusion to enhance cell expansion, persistence, and anti-tumor activity.
  • Intracranial catheter/reservoir for locoregional delivery — DEVICE
    A device (e.g., Ommaya reservoir) implanted in the brain to enable direct, repeated administration of CAR-NK cells or other therapies into the tumor site or cerebrospinal fluid, improving local drug delivery and reducing systemic exposure.
  • Fludarabine — DRUG
    A purine analog chemotherapy used in lymphodepletion prior to CAR-NK cell therapy to enhance the expansion, persistence, and anti-tumor activity of the infused cells.

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
Apr 24, 2026
Start date
Mar 2, 2026
Status verified
Apr 2026
Primary completion
Apr 14, 2027
Completion
Apr 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 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) after CAR-NK infusion (CTCAE v5.0; CRS and ICANS grading). [ Time Frame: 28 Days ]

Central Contacts

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