NCT07244666
Safety and Preliminary Efficacy of a Metabolically Armed Chimeric Antigen Receptor T Cell Therapy Targeting EGFRvIII for Recurrent Glioblastoma
Not Yet Recruiting · Early Phase 1 · Second Affiliated Hospital, Zhejiang University, School of Medicine · registry updated 2025-11-24
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
A Study of Metabolically Armed EGFRvII CAR-T Cells Therapy for Patients With Recurrent Glioblastoma
Inclusion
- All subjects or their legal guardians must personally sign the written informed consent form approved by the ethics committee in writing before starting any screening procedures;
- Age between 18 and 70 years old (inclusive), both male and female;
- Confirmed diagnosis of recurrent glioblastoma, as specified below:
- Previously diagnosed with glioblastoma through histopathological/ molecular pathology reports.
- Disease progression or recurrence confirmed by histopathology or imaging (defined as per RANO2.0 criteria as either progression/recurrence or lesions with abnormal enhancement accompanied by hypermetabolism or hyperperfusion changes) that are eligible for use when no standard treatment is available at enrollment;
- Positive EGFRvIII expression detected in tumor cells (confirmed through next-generation sequencing), and only eligible for patients who have previously received EGFRvIII-targeted therapy and relapsed, provided the EGFRvIII remains positive in post-relapse tumor samples;
Exclusion
- Subjects exhibiting other severe central nervous system disorders deemed by the investigator to be unrelated to the indication;
- Subjects anticipated to require systemic corticosteroid use within three months due to disease progression related to the indication;
- Subjects who have received the following medications:
- Corticosteroids at therapeutic doses (defined as prednisone \>20 mg/day, hydrocortisone \>20 mg/day, methylprednisolone \>4 mg/day, dexamethasone \>0.75 mg/day, betamethasone \>0.5 mg/day) within 7 days prior to leukapheresis or within 72 hours before CAR-T cell administration;
- Lymphocyte-toxic chemotherapy (e.g., cyclophosphamide, ifosfamide, bendamustine) administered within 2 weeks prior to leukapheresis;
- Investigational drugs from other clinical trials used within 4 weeks prior to blood collection. Exception: Patients whose prior trial medications were ineffective or whose disease progressed during the trial, provided at least 3 half-lives have elapsed since the last dose before leukapheresis;