Glioblastoma (GBM)Early Phase 1NCT07244666
Safety and Preliminary Efficacy of a Metabolically Armed Chimeric Antigen Receptor T Cell Therapy Targeting EGFRvIII for Recurrent Glioblastoma
A Early Phase 1 study testing Metabolically Armed EGFRvIII CAR-T cells in people with Glioblastoma (GBM), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
A Study of Metabolically Armed EGFRvII CAR-T Cells Therapy for Patients With Recurrent Glioblastoma Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Glioblastoma (GBM)
- What is being tested?
- Metabolically Armed EGFRvIII CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2025to 31 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- Karnofsky Performance Status (KPS) ≥60 points, ECOG score ≤2 (reconfirmed before CAR-T infusion);
- Measurable tumor lesions according to the Response Assessment in Neuro-Oncology (RANO 2.0);
- Adequate peripheral blood obtainable via venipuncture with no contraindications for lymphocyte collection, and sufficient peripheral blood cells collected for CAR-T cell preparation;
- Expected life expectancy ≥12 weeks;
- Adequate organ function (reconfirmed before CAR-T infusion):
- Complete blood count [must meet the following criteria within 24 hours prior to whole blood collection: avoid transfusions, platelet transfusions, and colony-stimulating factors (excluding recombinant erythropoietin) within 7 days before testing]:
- Blood Biochemistry: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤2.5 times ULN; serum creatinine ≤1.6 mg/dL; total bilirubin ≤1.5 mg/dL (except for subjects with GBM liver involvement and Gilbert syndrome patients, whose total bilirubin must be <3.0 mg/dL).
- Serology: Human immunodeficiency virus (HIV) antibody seronegative. The hepatitis B antigen test is negative, and the hepatitis C antibody test is negative. If the hepatitis C antibody test is positive, reverse transcription polymerase chain reaction (RT-PCR) must be performed to detect the presence of hepatitis B antigen and confirm that the hepatitis C virus (HCV) RNA is negative.
- Lung function: normal or grade 1 dyspnea according to CTCAE, SaO2 ≥ 92% in indoor air environment.
- Cardiac function: left ventricular ejection fraction (LVEF) ≥40% by echocardiography or radionuclide activity angiography (MUGA) within 1 month of enrollment.
- Coagulation function (at least including PT, APTT and INR) is within the normal range.
- Participants using the following medications must meet the following criteria:
- Corticosteroids: Treatment doses of corticosteroids must be discontinued 2 weeks prior to starting administration. However, physiological replacement doses of corticosteroids are permitted (hydrocortisone or equivalent <6-12 mg/mm²/day);
- At least 8 weeks must have elapsed between completing the last radiotherapy session and initiating treatment;
- At least 6 weeks must have passed since the completion of the last nitrosourea-based chemotherapy regimen;
- At least 14 days must have elapsed since the completion of the last temozolomide or other chemotherapy regimens before treatment initiation. If the subject has recently received targeted therapy and adverse events related to their targeted drug have resolved to baseline levels, screening may begin after a 2-week washout period (for bevacizumab, a total of 4 weeks of washout is required after confirming no bleeding caused by gastrointestinal ulcers). For long-term chronic low-grade (≤2) adverse events such as paronychia, eligibility will be determined by the investigator.
- The investigator determines that the subject has recovered from toxicity caused by prior anti-tumor treatment to grade 1 or below (except for special grade 2 or below toxicity that could not be recovered in a short period of time, such as hair loss), and is suitable for pre-treatment chemotherapy and CAR-T cell therapy.
- All male subjects and women of childbearing age must agree to use highly effective contraceptive methods for at least 12 months after LMC005 infusion until two consecutive PCR tests show no residual CAR-T cells in the body.
- Patients in the intraventricular injection group must additionally meet the following criteria: The investigator determines that the intracranial tumor is suitable for Ommaya sac implantation.
Who cannot join
- 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;
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- Radiotherapy received within 4 weeks prior to blood collection.
- Subjects with active hepatitis B (defined as hepatitis B surface antigen positivity or core antibody positivity with HBV DNA >1000 copies/mL) or active hepatitis C (HCV RNA positive);
- Subjects testing positive for HIV antibodies or Treponema pallidum antibodies;
- Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infections (e.g., positive blood culture ≤72 hours prior to LMC005 infusion);
- Subjects with unstable angina and/or myocardial infarction within 6 months prior to signing informed consent; or subjects with severe stroke or deep venous thrombosis (DVT) within 12 months prior to signing informed consent;
- Subjects with a history of or concurrent malignant tumors, except those meeting the following criteria:
- Surgically excised non-melanoma skin cancer;
- Curatively treated carcinoma in situ of the cervix;
- Localized prostate cancer;
- Low-stage bladder cancer;
- Ductal carcinoma in situ of the breast;
- Malignancies without recurrence or treatment within the past 2 years.
- Pregnant or lactating female subjects (women of childbearing potential with a positive pregnancy test result during screening);
- Subjects with active autoimmune diseases (e.g., Guillain-Barré syndrome, systemic lupus erythematosus);
- Subjects with a history of QT interval prolongation or other significant cardiac diseases;
- Subjects with contraindications to MRI scanning, including embedded metallic materials/devices (e.g., pacemakers);
- Other circumstances identified by the investigator as rendering the subject unsuitable for this study (e.g., poor compliance).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Chongran Sun, PhD, 86+15925612402, 2307010@zju.edu.cn
Chongran Sun, PhD
About this study
A Study of Metabolically Armed EGFRvII CAR-T Cells Therapy for Patients With Recurrent Glioblastoma
Read the detailed description
- Primary Objective Evaluate the safety and efficacy of metabolically armed EGFRvIII CAR-T cell injection in patients with recurrent glioblastoma.
- Secondary Objectives
Evaluate the pharmacokinetics/pharmacodynamic characteristics of metabolically armed EGFRvIII CAR-T cells in patients with recurrent glioblastoma and the persistence of the CAR-T cells in the subjects.
- Conditions
- Glioblastoma (GBM)
- Being tested
- Metabolically Armed EGFRvIII CAR-T cells
- Keywords
- Recurrent glioblastoma, EGFRvIII, metabolically armed, IL-10, CAR-T Cells Therapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolically Armed EGFRvIII CAR-T cellsDrug
Also called Meta10-EGFRvIII, LMC005
Patients will receive a single infusion of Meta10-EGFRvIII.
| Study group | Role | What they receive |
|---|---|---|
| Administration of Metabolically Armed EGFRvIII CAR-T cells | Experimental | Patients will be assigned to either the intraventricular injection group or the intravenous injection group, and receive a single infusion of Meta10-EGFRvIII on Day 0. Receives: Drug: Metabolically Armed EGFRvIII CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
To characterize the safety profile of Meta10-EGFRvIII in patients with recurrent glioblastoma as assessed by incidence of adverse events. Adverse events will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: up to 12 months
Secondary outcomes (1)
Objective response rate (ORR)
To evaluate the proportion of participants who have a confirmed partial response (PR) and complete response (CR) per RANO2.0 as assessed by the investigator.
Measured: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months after receiving the first dose of CAR-T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start15 Nov 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma (GBM)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Leman Biotech Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Chongran Sun, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244666
- Sponsor's protocol ID
- META10-EGFRvⅢ-010
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Preliminary Efficacy of a Metabolically Armed Chimeric Antigen Receptor T Cell Therapy Targeting EGFRvIII for Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT07244666
- Acronym / sponsor ID
- META10-EGFRvⅢ-010
- Conditions
- Glioblastoma (GBM)
- Keywords
- Recurrent glioblastoma, EGFRvIII, metabolically armed, IL-10, CAR-T Cells Therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Leman Biotech Co., Ltd.
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study of Metabolically Armed EGFRvII CAR-T Cells Therapy for Patients With Recurrent Glioblastoma
Detailed description
- Primary Objective Evaluate the safety and efficacy of metabolically armed EGFRvIII CAR-T cell injection in patients with recurrent glioblastoma.
- Secondary Objectives
Evaluate the pharmacokinetics/pharmacodynamic characteristics of metabolically armed EGFRvIII CAR-T cells in patients with recurrent glioblastoma and the persistence of the CAR-T cells in the subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of Metabolically Armed EGFRvIII CAR-T cells | Experimental | Drug: Metabolically Armed EGFRvIII CAR-T cellsPatients will be assigned to either the intraventricular injection group or the intravenous injection group, and receive a single infusion of Meta10-EGFRvIII on Day 0. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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:
- 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;
- Karnofsky Performance Status (KPS) ≥60 points, ECOG score ≤2 (reconfirmed before CAR-T infusion);
Key exclusion criteria (23 listed)
- 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:
- Subjects with active hepatitis B (defined as hepatitis B surface antigen positivity or core antibody positivity with HBV DNA >1000 copies/mL) or active hepatitis C (HCV RNA positive);
- Subjects testing positive for HIV antibodies or Treponema pallidum antibodies;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolically Armed EGFRvIII CAR-T cellsAlso: Meta10-EGFRvIII, LMC005Patients will receive a single infusion of Meta10-EGFRvIII. | Drug | Administration of Metabolically Armed EGFRvIII CAR-T cells |
Primary outcome
Adverse Events (AEs)
Time frame: up to 12 months
To characterize the safety profile of Meta10-EGFRvIII in patients with recurrent glioblastoma as assessed by incidence of adverse events. Adverse events will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
1 secondary outcome
Objective response rate (ORR)
Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 months after receiving the first dose of CAR-T cell infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chongran Sun, PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Metabolically Armed EGFRvIII CAR-T cells in people with Glioblastoma (GBM), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chongran Sun, PhD (86+15925612402, 2307010@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.