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This study explores the safety and efficacy of intraventricular HER2-CAR T cells in patients with CNS metastases.

November 1, 2025Neuro-OncologyOpen Access

Ctim-07. A Phase 1 Study of Intraventricularly Administered Autologous Her2-Targeting Chimeric Antigen Receptor T Cells (Her2-Car T Cells), With and Without Lymphodepletion, in Her2-Positive Breast Cancer Patients With Recurrent Brain and/or Leptomeningeal Metastases

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This study explores the safety and efficacy of intraventricular HER2-CAR T cells in patients with CNS metastases.
Participants received one of three HER2-CAR T cell dose levels.
Treatment included either CAR T cells alone or with lymphodepletion using fludarabine/cyclophosphamide.
CSF samples were analyzed for cytokine changes before and after treatment.
Twenty-three participants received HER2-CAR T cells with a median of 5 doses.
Stable disease was observed in 44% with CAR T only and 64% in the lymphodepletion group.
Adverse events included headaches and flu-like symptoms, with some dose-limiting toxicities reported.

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Phase 1 study shows safety of HER2-CAR T cells in HER2-positive breast cancer, suggesting potential for future treatment.

Portnow et al. (2025) studied this question.

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