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Published on: September 1, 2018
Phase 1 study of intracranial T cell therapy with pemetrexed for refractory brain metastases and glioblastomas
Congcong Li1, Shuang Wang2, Xiumei Rong3
1Department of Medical Oncology, Fudan University Pudong Medical Center, Shanghai 201399, P.R. China; Solid Tumor Cell Therapy Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, P.R. China.
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 × 108 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).
Insights
This study shows that SCOPE-T, an intracranial treatment for brain tumors, is safe and feasible. Early results suggest it may help stabilize disease in patients with advanced brain malignancies.
Area of Science:
- Neuro-oncology
- Immunotherapy
- Drug Delivery
Background:
- Limited therapeutic options exist for advanced intracranial malignancies like glioblastomas and brain metastases.
- Patients often become ineligible for standard treatments such as surgery, radiotherapy, or systemic therapies.
- There is a critical need for novel treatment strategies in refractory cases.
Purpose of the Study:
- To evaluate 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 (SCOPE-T).
- To assess preliminary therapeutic activity in patients with refractory intracranial malignancies.
Main Methods:
- Phase 1 clinical trial involving 25 patients with refractory intracranial malignancies.
- Intracranial administration of pemetrexed, followed by RAKs and interleukin 2 via an Ommaya reservoir (SCOPE-T).
- Dose escalation of RAKs up to 5 × 108 cells.
Main Results:
- Treatment was well tolerated, with no treatment-related adverse events exceeding grade 2.
- The most common toxicities were transient fever and headache.
- Exploratory assessments indicated disease stabilization in evaluable patients.
- Nineteen patients completed at least one treatment cycle, and 17 received the maximum RAK dose.
Conclusions:
- Intracranial SCOPE-T is feasible and safe for patients with refractory intracranial malignancies.
- Preliminary signals of therapeutic activity warrant further investigation.
- Results are exploratory due to the small sample size and non-randomized design (ClinicalTrials.gov: NCT05459441).
