Health Trials

About this trial

This is a Phase II trial to evaluate the safety, tolerability, efficacy, and PK/ pharmacodynamic profiles of MT027 injected via ICV in participants with recurrent or progressive IDH-wildtype glioblastoma (WHO 2021 CNS Grade 4), who have previously received standard of care (SOC) therapy.

Each participant will undergo screening, treatment (receiving MT027 at a dose of 3×10\^7 cells), safety follow-up, and long-term follow-up periods.

MT027 will be given via ICV injection on Day 1 \& Day 15 of the first 28-day cycle. If the participant does not experience any unacceptable toxicities and disease progress in the first cycle, additional treatment may be continued bi-weekly in a 28-day cycle (Days 1 \& Day 15 of the 28-day cycle) until intolerable toxicity, disease progression, withdrawal from the study, or death, whichever comes first. After the last dose, there will be a safety follow-up period lasting for 1 year and then a long-term follow-up up to 15 years.

Eligibility criteria

Qualifiers

Written informed consent must be obtained prior to any procedures that are not considered SOC

≥ 18 years old and ≤ 70 years old on the day of signing informed consent, male or female

According to the histological/molecular pathology, diagnosed with GBM WHO grade 4

According to the histopathology or radiological imaging, confirmed disease progression or recurrence

Disqualifiers

Brainstem and thalamus recurrence, spinal cord dissemination or extracranial metastasis

The largest diameter of a single tumor lesion > 5 cm, or the sum of the largest diameters of multiple lesions > 6 cm

Symptoms and signs of chronic intracranial hypertension that are difficult to control with drugs (such as daily use of Mannitol > 500 mL or Dexamethasone > 15 mg or Methylprednisolone > 80 mg or other hormones at the same dose)

Uncontrolled seizure or epilepsy aggravation requiring escalation of antiepileptic therapy over the last 4 weeks

Trial design

Treatments tested in this trial

  • Intracerebroventricular injection of MT027 UCAR-T Cell targeting B7H3

Treatment groups

40 Participants
are divided into 1 treatment group

Locations

4
Taiwan
Hualien Tzu Chi Hospital970473, Hualien City Taiwan
Chang Gung Memorial Hospital, Kaohsiung833401, Kaohsiung City Taiwan
Chang Gung Memorial Hospital, Linkou333423, Taoyuan Taiwan
United States
The Johns Hopkins Sidney Kimmel Cancer Center21287, BaltimoreMaryland, United States

Sponsors and collaborators

T-MAXIMUM Pharmaceutical Inc

Lead sponsor

Virginia Contract Research Organization Co., Ltd.

Collaborator

Source ClinicalTrials.gov