Comparison of Cerebraca Wafer Plus Temozolomide Versus Temozolomide Alone in Recurrent Glioblastoma

Recruitment Status
NOT YET RECRUITING
(See Contacts and Locations)Verified December 2025 by Everfront Biotech Co., Ltd.
Sponsor
Everfront Biotech Co., Ltd.
Information Provided by (Responsible Party)
Everfront Biotech Co., Ltd.
Clinicaltrials.gov Identifier
NCT07349693
Other Study ID Numbers:
EFBPOLZ-1
First Submitted
January 14, 2026
First Posted
January 19, 2026
Last Update Posted
January 19, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on January 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Recurrent Glioblastoma, IDH-Wildtype
Drug: Cerebraca waferDrug: Temozolomide (for relapsed malignant glioma)

Study Design

Study TypeInterventional
Actual Enrollment175 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Randomized Trial to Assess the Efficacy and Safety of Cerebraca Wafer Plus Temozolomide Versus Temozolomide Alone in Recurrent Glioblastoma
Study Start Date2mos 1w from now
Actual Primary Completion Date2yrs 3mos from now
Actual Study Completion Date4yrs 3mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Treatment Group (Cerebraca Wafer)
Patients will receive surgical tumor resection, implantation of 6 Cerebraca Wafer (75 mg each, total dose of 450 mg (Z)-BP) at the time of surgery, followed by SOC TMZ therapy.
Drug: Cerebraca wafer
Cerebraca Wafer, (75 mg (Z)-n-butylidenephthalide, (Z)-BP, Implant)
Comparative Group (Standard-of-Care)
Patients will receive surgical tumor resection, followed by SOC TMZ therapy.
Drug: Temozolomide (for relapsed malignant glioma)
TMZ as the standard-of-care (SOC) treatment for recurrent glioblastoma.

Outcome Measures

Primary Outcome Measures
  1. Median overall survival (OS)
    Median overall survival (OS) in recurrent glioblastoma patients (event-based)
Secondary Outcome Measures
  1. Tolerability and Safety Profile
    Number of participants with treatment-related adverse events and serious adverse events as assessed by CTCAE v5.0"
  2. Survival rate
    To evaluate survival rate post resection.
  3. Median progression-free survival (PFS)
    To determine the median progression-free survival (PFS) in recurrent glioblastoma patients.
  4. PFS rate
    To evaluate PFS rate at 6, 9, and 12 months post resection

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Inclusion Criteria, subjects must meet all following criteria for study enrollment: 1. Subject must be aged ≥ 18, regardless of gender 2. Subject must have histologically confirmed glioblastoma with: 1. Completed first-line therapy including surgery plus temozolomide and radiation (concurrent temozolomide/radiation) 2. Current presentation being first or second recurrence only 3. Subject must have measurable disease preoperatively with at least one contrast-enhancing MRI-identified lesion measuring ≥ 1 cm in two perpendicular dimensions per RANO 2.0 criteria 4. Subject must be deemed eligible for gross total resection of contrast-enhancing MRI-identified lesion by neurosurgeon's pre-operative assessment, according to RANO II 5. Subject must have Karnofsky Performance Status (KPS) ≥ 70 6. Subject must have recovered from prior therapy toxicities with adequate organ function: 1. Hemoglobin ≥ 8 g/dL 2. Platelets ≥ 100,000/mm3 3. White blood cell count (WBC) ≥ 3,000 cells/mm3 4. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 5. Absolute lymphocyte count (ALC) ≥ 1,000 cells/mm3 6. Coagulation tests (prothrombin time \[PT\], activated partial thromboplastin time \[APTT\], International Normalized Ratio \[INR\]) ≤ 1.5 × ULN 7. Total bilirubin (TBIL) \< 3 × ULN 8. Alkaline phosphatase (ALP) ≤ 3 × ULN and/or Gamma glutamyltransferase (GGT) ≤ 1.5 × ULN 9. Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and/or Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 3 x ULN 10. eGFR ≥ 30 mL/min (MDRD formula) 11. QTc interval: msec ≤ 450 (males) or 470 (females) (Fridericia's formula: QTc=QT/RR(1/3); RR=RR interval)
Exclusion Criteria
Inclusion Criteria, subjects must meet all following criteria for study enrollment: 1. Subject must be aged ≥ 18, regardless of gender 2. Subject must have histologically confirmed glioblastoma with: 1. Completed first-line therapy including surgery plus temozolomide and radiation (concurrent temozolomide/radiation) 2. Current presentation being first or second recurrence only 3. Subject must have measurable disease preoperatively with at least one contrast-enhancing MRI-identified lesion measuring ≥ 1 cm in two perpendicular dimensions per RANO 2.0 criteria 4. Subject must be deemed eligible for gross total resection of contrast-enhancing MRI-identified lesion by neurosurgeon's pre-operative assessment, according to RANO II 5. Subject must have Karnofsky Performance Status (KPS) ≥ 70 6. Subject must have recovered from prior therapy toxicities with adequate organ function: 1. Hemoglobin ≥ 8 g/dL 2. Platelets ≥ 100,000/mm3 3. White blood cell count (WBC) ≥ 3,000 cells/mm3 4. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 5. Absolute lymphocyte count (ALC) ≥ 1,000 cells/mm3 6. Coagulation tests (prothrombin time \[PT\], activated partial thromboplastin time \[APTT\], International Normalized Ratio \[INR\]) ≤ 1.5 × ULN 7. Total bilirubin (TBIL) \< 3 × ULN 8. Alkaline phosphatase (ALP) ≤ 3 × ULN and/or Gamma glutamyltransferase (GGT) ≤ 1.5 × ULN 9. Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and/or Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 3 x ULN 10. eGFR ≥ 30 mL/min (MDRD formula) 11. QTc interval: msec ≤ 450 (males) or 470 (females) (Fridericia's formula: QTc=QT/RR(1/3); RR=RR interval) Exclusion Criteria, subjects with any of the following will be excluded: 1. Histological confirmation of oligodendroglioma or mixed glioma 2. Presence of IDH or H3K27M mutation, or 1p19q co-deletion 3. MRI-identified lesion meeting any criteria: 1. Multi-focal (defined as 2 non-contiguous contrast enhancement areas \> 1 cm in 2 planes on fluid-attenuated inversion recovery, FLAIR or T2-weighted sequences) 2. Presence of diffuse subependymal or leptomeningeal dissemination 3. Contrast-enhancing lesion \> 6 cm in any dimension 4. Tumor location unsuitable for surgical resection and Cerebraca Wafer implantation in the brain areas where surgical intervention would cause significant neurological deficits 5. Prior bevacizumab treatment with uncontrollable tumor progression 6. History of other malignancy within past 5 years 7. Immunocompromised status or autoimmune conditions requiring systemic immunosuppressive therapy, with the following exceptions: 1. Patients with autoimmune conditions may be eligible after individual assessment of the condition, its severity, and potential interaction with the Cerebraca Wafer. 2. Patients with HIV infection are eligible if they: i. Have CD4+ T-cell counts ≥350 cells/μL ii. Are on stable anti-retroviral therapy iii. Have HIV viral load below the limit of quantification c. Patients with HBV infection are eligible if they: i. Are on appropriate suppressive anti-viral therapy prior to study enrollment ii. Have no evidence of hepatic decompensation d. Patients with history of HCV infection are eligible if they: i. Have completed curative anti-viral treatment with HCV viral load below the limit of quantification 8. Active, uncontrolled infection or medical condition that could compromise safety and efficacy assessment

Contacts and Locations

Sponsors and CollaboratorsEverfront Biotech Co., Ltd.
Locations
Legorreta Cancer Center Warren Alpert Medical School of Brown University | Providence Rhode Island, United States, 02903