Actively Recruiting
An Open-label, First-in-human Study of EPC-003 Fully Human B7H3/IL13Ra2 Bispecific Armored CAR-T Cell Therapy for Recurrent or Refractory Glioblastoma with Dose-escalation and Dose-expansion
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-11-18
14
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of EPC-003, a fully human bispecific armored Chimeric Antigen Receptor T-Cell Therapy (CAR-T), in treating patients with recurrent or refractory glioblastoma. This Phase I, open-label study involves individuals whose glioblastoma has returned or not responded to standard treatments, focusing on those with tumors expressing specific markers B7H3 and/or IL13Ra2. The trial aims to find the maximum tolerated dose and recommended dose for further studies while monitoring adverse effects. The trial is divided into two phases: dose-escalation and dose-expansion. In the dose-escalation phase, four dose levels of EPC-003 CAR-T cells (ranging from 2.5 to 20 million cells) are administered weekly via intraventricular injection through an Ommaya reservoir, totaling six doses. Dose escalation follows a careful stepwise design to identify safe dosing limits. The dose-expansion phase enrolls six additional patients at the highest tolerable dose to confirm safety and optimal dosing. The infusion schedule may be adjusted based on patient response and safety. Participants undergo a screening period lasting about two weeks to confirm eligibility, including disease status and treatment history. During the study, they receive weekly cell infusions and are closely monitored for safety, including adverse events within 28 days after the first infusion. Researchers will assess tumor response, disease control, progression-free survival, and overall survival over a 12-month follow-up. The study involves laboratory tests, imaging, and clinical assessments to evaluate therapy effects and participant health throughout the trial, which may last up to one year or more.
CONDITIONS
Brief 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 comply with the trial treatment plan and visit schedule and sign informed consent.
- Aged between 18 and 75 years at the time of consent.
- Karnofsky Performance Status score of 60% or higher.
- Have B7H3- and/or IL13Ra2-positive recurrent or refractory glioblastoma confirmed by histopathology or cytology.
- Disease progression or recurrence after standard treatment including radiotherapy and chemotherapy.
- At least one measurable lesion with size criteria.
- Expected survival time of at least 12 weeks.
- Adequate organ function based on specified laboratory tests.
- Agree to use effective contraception during and for one year after treatment; negative pregnancy test for women of childbearing age.
You will not qualify if you...
- Lesion located in posterior fossa structures like cerebellum, pons, or medulla oblongata.
- Presence of meningeal metastasis or malignant tumor cells in cerebrospinal fluid.
- Uncontrolled epilepsy or high intracranial pressure.
- Other central nervous system diseases or history within 6 months.
- Diagnosed with other malignant tumors within 5 years, except certain treated cancers.
- Previous treatment targeting B7H3/IL13Ra2.
- Prior gene or cell therapy.
- Long-term use of immunosuppressive drugs or high-dose steroids (except inhaled hormones for asthma).
- Previous allogeneic hematopoietic stem cell transplantation or planned autologous transplantation.
- Active infections including bacterial, viral, fungal, hepatitis B, C, HIV, or syphilis.
- Pregnant or lactating women.
- Unstable systemic diseases including serious heart, lung, liver, kidney, digestive, or metabolic conditions.
- Recent anticoagulant therapy or anti-tumor treatments within specified timeframes.
- Recent radiotherapy or major surgery with incomplete recovery.
- Investigator judgment deeming unsuitability for participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive weekly infusions of EPC-003 CAR-T cells into the Ommaya reservoir at escalating doses over six weeks to evaluate safety and efficacy.
Weekly visits for 6 weeks (in-person)
Duration - Up to 12 months
Participants are monitored for safety and treatment response for up to 12 months after the last CAR-T cell infusion.
Regular follow-up visits during the 12-month period
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
S
Shuyu Zheng, MD
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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