Clinical Trial

Disease: Recurrent or Progressive High-grade Glioma, (NCT06737146)

Disease info:

Gliomas are a diverse group of tumours originating from glial cells in the brain and spinal cord, representing the most common primary brain tumour within the central nervous system. In the United States, there are 6 cases of gliomas diagnosed per 100,000 individuals annually, with an estimated 80,000 to 90,000 newly diagnosed primary brain tumours each year, approximately 25% being gliomas.

These tumours are classified into three main types based on their cell of origin: astrocytomas (from astrocytes), oligodendrogliomas (from oligodendrocytes), and ependymomas (from ependymal cells). The World Health Organisation grading system, now incorporating molecular markers such as IDH mutations and 1p/19q co-deletions, classifies gliomas from grade 1 (low-grade) to grade 4 (high-grade), with significant prognostic and therapeutic implications.

Common symptoms include headaches, seizures, nausea, vomiting, and focal neurological deficits. Diagnosis relies primarily on magnetic resonance imaging, with tissue sampling providing molecular characterisation essential for treatment planning.

Treatment approaches vary by grade and typically involve maximal safe surgical resection as the mainstay, followed by radiotherapy and chemotherapy for higher-grade tumours. The Stupp protocol (radiotherapy with concurrent temozolomide) remains the standard of care for high-grade gliomas. Low-grade gliomas generally have more favourable prognoses, whilst high-grade gliomas, particularly glioblastomas, have poorer outcomes due to their aggressive nature and high recurrence rates.

Recent advances in molecular profiling have led to more precise classification and targeted therapies, though the diffuse and infiltrative nature of high-grade gliomas continues to pose significant treatment challenges.

Source: StatPearls

Frequency:
In the United States, there are 6 cases of gliomas diagnosed per 100,000 individuals annually, with an estimated 80,000 to 90,000 newly diagnosed primary brain tumours each year, approximately 25% being gliomas.
Official title:
A Single-arm, Dose-escalation Phase I Clinical Study on Evaluating the Tolerability, Pharmacokinetic Characteristics, Safety and Preliminary Efficacy of MT027 in Patients with Recurrent or Progressive High-grade Glioma
Who:

Study Contact:

Name: Guangyuan Hu

Phone Number: +86-027-83663405

Email: h.g.y.121@163.com

Sponsor:

Suzhou Maximum Bio-tech Co., Ltd.

Partners:
Locations:

China, Hubei Wuhan, 430030 Recruiting Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Contact: Guangyuan Hu +8602783663405 h.g.y.121@163.com

Contact: Lei Huang +8615962138334 huanglei@t-maximum.com

Study start:
Jan. 1, 2025
Enrollment:
12
Gene editing method:
CRISPR-Cas
Type of edit:
Gene insertion
Gene:
Gene expressing a CAR that targets B7-H3
Delivery method:
- Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Not yet recruiting

Description

The clinical protocol plans to preset three dose groups, namely 1×10⁷ cells per dose, 3×10⁷ cells per dose, and 6×10⁷ 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.

Last updated: Jun. 26, 2025
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