Phase 1 study of intracranial T cell therapy with pemetrexed for refractory brain metastases and glioblastomas.
other · Level V
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- Record sourced from PubMed, PMID 42556340.
- Also identified by DOI 10.1016/j.xcrm.2026.102967.
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Abstract
Therapeutic options remain limited for advanced intracranial malignancies, including brain metastases and glioblastomas, particularly in patients ineligible for surgery, radiotherapy, or systemic therapies. This phase 1 study evaluates the safety and feasibility of intracranial administration of low-dose pemetrexed followed by RetroNectin-activated killer cells (RAKs) and interleukin 2 via an Ommaya reservoir (collectively referred to as SCOPE-T) in 25 patients with refractory intracranial malignancies. Nineteen patients completed at least one treatment cycle, and 17 received the maximum tested RAK dose (5 × 10<sup>8</sup> cells). Treatment is well tolerated, with no treatment-related adverse events greater than grade 2; transient fever and headache are the most common toxicities. Exploratory radiographic and clinical assessments suggest disease stabilization in evaluable patients. These findings support the feasibility and safety of intracranial SCOPE-T and indicate preliminary signals of therapeutic activity. Given the small sample size and non-randomized design, the results should be interpreted as exploratory (ClinicalTrials.gov: NCT05459441).