Study of MT027 in Patients with Recurrent or Progressive High-grade Glioma
Status:
NOT_YET_RECRUITING
Trial end date:
2026-12-30
Target enrollment:
Participant gender:
Summary
The clinical protocol plans to preset three dose groups, namely 110 cells per dose, 310 cells per dose, and 610 cells per dose. The injection will be administered once every three weeks, adopting a "3 + 3" dose escalation design. The dosing interval is based on the pharmacokinetic (PK), safety and preliminary efficacy data of MT027 investigator-initiated trial (IIT) previously conducted at Dushu Lake Hospital of Soochow University. Accordingly, it is recommended to maintain the dosing interval of once every three weeks, with a window period of 7 days. According to past experience, the dosing cycle should be at least 6 cycles, with each cycle lasting 21 days. If patients still benefit after more than 6 cycles, they can continue to receive the medication until no further benefit is achieved. The number of treatment sessions is approximately 6 to 9 times. However, the specific number of treatment sessions will generally be determined by the investigator based on the patient's disease condition.