drugset / Trial / NCT05459441

Efficacy and Safety Evaluation of Percutaneous Ommaya Capsule Injection of Autologous Bi-dimensional Specific T Cells in the Treatment of Glioma and in Combination With Pemetrexed in the Treatment of Brain/Meningeal Metastases

NCT05459441

Phase 0 Unknown 30 enrolled Shanghai Pudong Hospital
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Cerebral metastases are common intracranial tumor, its incidence increased year by year, in recent years, although the whole brain radiation therapy, surgical resection, stereotactic radiosurgery treatment, targeted drugs, and other comprehensive treatment in patients with symptoms of mitigation and the extension of survival has played a positive role, but due to individual differences, treatment in patients with poor compliance were a lot of factors, Further treatment of brain metastases after conventional treatment requires the assistance and cooperation of clinical multi-disciplines. To evaluate the efficacy and safety of percutaneous Ommaya capsule injection of autologous bi-dimensional specific T cells in the treatment of glioma and combined with pemetrexed in the treatment of brain/meningeal metastasis. Using translational research techniques and means, to find molecular indicators related to clinical prognosis and outcome, establish the clinical use standard of this holistic treatment technology, and popularize it in multi-centers.

Timeline

Start
2022-01-01
Primary completion
2023-06-30
Completion
2023-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pemetrexed Small molecule 10 mg Intrathecal
Subject RAK cells Cell therapy Other