Actively Recruiting
B7H3/IL13Ra2 Bispecific Armored Chimeric Antigen Receptor T-Cell Therapy Study for Recurrent/Refractory Glioblastoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-11-18
14
Participants Needed
1
Research Sites
170 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an investigator-initiated, open-label Phase I clinical trial designed to evaluate the safety and efficacy of EPC-003 fully human anti-B7H3/IL13Ra2 armored Chimeric Antigen Receptor T-Cell Therapy (CAR-T) cell injection in patients with recurrent or refractory glioblastoma. Approximately 14 patients with relapsed or refractory glioblastoma are planned to be enrolled in this trial. During the screening period (Days -28 to -15), subjects will undergo relevant examinations or observations to confirm the disease status, treatment history, and other related information. Subjects who meet the screening criteria will be enrolled in the clinical trial to receive EPC-003 treatment. Specifically, they will receive intraventricular injection of EPC-003 via Ommaya reservoir on Day 0 (D0), Day 7 (D7), Day 14 (D14), Day 21 (D21), Day 28 (D28), and Day 35 (D35), once a week, totaling 6 administrations. All CAR-T cell infusions will be delivered via intraventricular injection. This trial comprises two phases: the first phase is the dose-escalation phase, and the second phase is the dose-expansion phase.
CONDITIONS
Official Title
B7H3/IL13Ra2 Bispecific Armored Chimeric Antigen Receptor T-Cell Therapy Study for Recurrent/Refractory Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agree to follow the trial treatment plan and visit schedule, voluntarily enroll, and sign informed consent.
- Be between 18 and 75 years old at the time of signing informed consent, any gender.
- Have a Karnofsky Performance Status (KPS) score of 60% or higher.
- Have recurrent or refractory glioblastoma positive for B7H3 and/or IL13Ra2 by pathology or cytology with expression rates above 30%.
- Show disease progression or recurrence after standard treatment including surgery, radiotherapy, and chemotherapy with temozolomide.
- Have at least one measurable lesion with perpendicular diameters of 10 mm or more.
- Have an expected survival time of at least 12 weeks.
- Have adequate organ function based on specified blood counts, liver and kidney tests, coagulation, and heart function.
- Agree to use effective contraception from signing consent until one year after the last study drug administration; females must have a negative pregnancy test within 7 days before drug administration.
You will not qualify if you...
- Lesion located in posterior fossa structures such as cerebellum, pons, or medulla oblongata.
- Presence of meningeal metastasis or malignant tumor cells in cerebrospinal fluid.
- Uncontrolled epilepsy or high intracranial pressure.
- Other active or recent (within 6 months) central nervous system diseases like stroke or autoimmune CNS disorders.
- Diagnosis of other malignant tumors within 5 years, except certain treated localized cancers.
- Previous treatment targeting B7H3/IL13Ra2.
- Previous gene therapy or cell therapy.
- History of long-term immunosuppressive or high-dose steroid use (except inhaled hormones for chronic bronchial conditions).
- Prior allogeneic hematopoietic stem cell transplantation or planned autologous transplantation.
- Uncontrolled active infections.
- Unstable systemic diseases including serious cardiovascular, pulmonary, liver, kidney, digestive, or metabolic conditions.
- Recent oral anticoagulant therapy within 1 week before CAR-T infusion.
- Recent anti-tumor therapy within 4 weeks before infusion or unresolved toxicities above grade 1.
- Radiotherapy within 12 weeks before infusion unless disease progression outside irradiated area is confirmed.
- Recent major surgery or trauma within 4 weeks before consent or planned major surgery during trial.
- Positive tests for active hepatitis B or C, HIV, or syphilis infection.
- Pregnant or breastfeeding women.
- Any other conditions judged by investigators to affect compliance or suitability for the trial.
AI-Screening
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Trial Site Locations
Total: 1 location
1
the Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 210000
Actively Recruiting
Research Team
F
Feng Yan, MD, PhD
CONTACT
S
Shuyu Zheng, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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