BridgeMD
New treatment option for Refractory Glioblastoma
Official title B7H3/IL13Ra2 Bispecific Armored Chimeric Antigen Receptor T-Cell Therapy Study for Recurrent/Refractory Glioblastoma
ClinicalTrials.gov ID: NCT07193628
What this study is testing
What is EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 1)?
EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 1) is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for refractory glioblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1: Agree to comply with the trial treatment plan and visit schedule, voluntarily enroll in the trial, and sign the informed consent form in writing.
- 2: On the day of signing the informed consent form, the subject shall be aged between 18 and 75 years inclusive, with no restriction on gender.
- 3: Karnofsky Performance Status (KPS) score ≥ 60%
- 4: Patients with B7H3- and/or IL13Ra2-positive recurrent or refractory glioblastoma confirmed by histopathology and/or cytology, meeting the...
- 5: Expected survival time ≥ 12 weeks;
You likely can't join if
- 1: The lesion is located in the posterior fossa structures such as the cerebellum, pons, and medulla oblongata.
- 2: Complicated with meningeal metastasis or detectable malignant tumor cells in cerebrospinal fluid.
- 3: Presence of epilepsy and/or high intracranial pressure that cannot be controlled or stabilized with medication.
- 4: people with current comorbid other central nervous system (CNS) diseases or a history of CNS diseases within 6 months prior to screening, such as...
- 5: people who have been diagnosed with other malignant tumors within 5 years prior to screening, excluding adequately treated carcinoma in situ of...
- 6: people who have previously received treatment targeting B7H3/IL13Ra2.
See the full eligibility criteria
- 1: Agree to comply with the trial treatment plan and visit schedule, voluntarily enroll in the trial, and sign the informed consent form in writing.
- 2: On the day of signing the informed consent form, the subject shall be aged between 18 and 75 years inclusive, with no restriction on gender.
- 3: Karnofsky Performance Status (KPS) score ≥ 60%
- 4: Patients with B7H3- and/or IL13Ra2-positive recurrent or refractory glioblastoma confirmed by histopathology and/or cytology, meeting the following criteria: The positive expression rate of B7H3 \> 30%; The positive...
- 5: Expected survival time ≥ 12 weeks;
- 6: people must have adequate organ function, meeting the following laboratory test criteria: Bone Marrow Function: Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L; Platelet Count (PLT) ≥ 100×10⁹/L; Absolute Lymphocyte Count...
- 7: Male people with reproductive potential and female people of childbearing age must agree to use effective contraceptive measures from the time of signing the informed consent form until 1 year after the last...
- 1: The lesion is located in the posterior fossa structures such as the cerebellum, pons, and medulla oblongata.
- 2: Complicated with meningeal metastasis or detectable malignant tumor cells in cerebrospinal fluid.
- 3: Presence of epilepsy and/or high intracranial pressure that cannot be controlled or stabilized with medication.
- 4: people with current comorbid other central nervous system (CNS) diseases or a history of CNS diseases within 6 months prior to screening, such as uncontrolled cerebrovascular accident, transient ischemic attack...
- 5: people who have been diagnosed with other malignant tumors within 5 years prior to screening, excluding adequately treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, localized...
- 6: people who have previously received treatment targeting B7H3/IL13Ra2.
- 7: people who have previously received gene therapy or cell therapy.
- 8: people who have a history of long-term use of immunosuppressive drugs or high-dose steroid hormones; inhaled hormones used for the treatment of chronic bronchial inflammation or asthma are not affected.
- 9: people who have previously received allogeneic hematopoietic stem cell transplantation; or those who are eligible for and agree to undergo autologous hematopoietic stem cell transplantation.
- 10: Uncontrolled active bacterial, viral, or fungal infection.
- 11: Any unstable systemic disease, including but not limited to cardiovascular diseases such as unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (New York...
- 12: people who have received oral anticoagulant therapy within 1 week prior to CAR-T cell infusion.
- 13: people who have received anti-tumor therapy (including chemotherapy, targeted therapy, immunotherapy, TTfield therapy, investigational trial drugs, and other anti-tumor treatments) within 4 weeks prior to cell...
- 14: people who have received radiotherapy within 12 weeks prior to cell infusion (those with progressive disease outside the irradiated field or those in whom pseudo-progression after radiotherapy/chemotherapy can be...
- 15: people who have undergone major surgery or significant traumatic injury within 4 weeks prior to informed consent, or have not recovered from the side effects of surgery, or plan to undergo major surgery during the...
- 16: Positive for hepatitis B surface antigen (HBsAg); positive for hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA quantitative test result above the lower limit of detection; positive for hepatitis C...
- 17: Pregnant or lactating women.
- 18: Investigators consider that the subject has other conditions that may affect compliance or make them unsuitable for participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.