The GLIOMAX Study: MT027 Allogeneic CAR-T for Recurrent Glioma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorT-MAXIMUM Pharmaceutical Inc
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Intracerebroventricular injection of MT027 UCAR-T Cell targeting B7H3
Biological/VaccineMT027 will be injected intracerebroventricularly at a dose of 3×10\^7 cells on Day 1 \& Day 15 of each 28-day treatment cycle.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: MT027Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence rate of Dose-limiting toxicity (DLT)
Incidence rate of Dose-limiting toxicity (DLT) after treatment in the safety run-in stage
Time frame
From the first dose to 2 weeks after the second dose2
12-month overall survival (OS) rate
Time frame
From the first dose to 12 months after the treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
T-MAXIMUM Pharmaceutical Inc
Lead sponsor
Virginia Contract Research Organization Co., Ltd.
Collaborator
Source ClinicalTrials.gov
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