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

ConditionsGlioblastomaHigh-grade GliomaMalignant GliomaRecurrent GlioblastomaRecurrent High-grade Glioma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Biotech

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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: IL13Rα2, EGFR (wild-type) and/or EGFRvIII, B7-H3 (CD276).

Disqualifiers

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).

Trial design

Design model

Sequential

Treatments tested in this trial

  • Dual-target CAR-NK cells

    Biological/Vaccine

    Dual-target CAR-NK cells

  • Cyclophosphamide

    Drug

    Cyclophosphamide

  • Fludarabine

    Drug

    Fludarabine

  • Intracranial catheter/reservoir for locoregional delivery

    Device

    Intracranial catheter/reservoir for locoregional delivery

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: IL13Rα2 + EGFR/EGFRvIII Dual-Target CAR-NKExperimental treatment 4 interventions
Group B: IL13Rα2 + B7-H3 (CD276) Dual-Target CAR-NKExperimental treatment 4 interventions
Group C: EGFR/EGFRvIII + B7-H3 (CD276) Dual-Target CAR-NKExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicities (DLTs)

Incidence of dose-limiting toxicities (DLTs) after CAR-NK infusion (CTCAE v5.0; CRS and ICANS grading).

Time frame
28 Days
2

Maximum tolerated dose (MTD)

Time frame
12 months

Secondary outcomes

1

Objective response rate (ORR)

Objective response rate (ORR) by RANO criteria (CR+PR).

Time frame
12 months
2

Disease control rate (DCR)

Time frame
6 months
3

Progression-free survival (PFS)

Time frame
24 months
4

Overall survival (OS)

Time frame
24 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Biotech

Lead sponsor

Source ClinicalTrials.gov
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