[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-glioblastoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-glioblastoma":22},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,36],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":18,"phases":4,"briefSummary":19,"conditions":20,"keywords":24,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":32,"locationsCount":35},"100547135","expanded-access-to-gallium-maltolate-gam-100547135",false,"NCT06404034","Expanded Access to Gallium Maltolate (GaM)","Expanded Access to Gallium Maltolate (GaM) for Adult Patients With Relapsed\u002FRefractory Histologic or Molecular Glioblastoma","Inclusion Criteria:\n\n1. Patient has relapsed\u002Frefractory histologic or molecular glioblastoma who, in the opinion of the treating physician, may benefit from treatment from GaM.\n2. Male or female patient aged ≥ 18 years.\n3. In the opinion of the treating physician, the patient has adequate organ function to tolerate GaM.\n4. Patient must be able to swallow and retain orally administered medication.\n5. For females of childbearing potential, negative urinary or serum pregnancy test.\n6. Patients must be willing to highly effective contraception for both male and female patients throughout the treatment and for at least 4 months after last treatment administration.\n7. Toxicities related to any prior treatments are either stable, stable on supportive therapy, resolved, or in the opinion of the treating physician, clinically non-significant.\n8. Ability to understand a written informed consent document, and the willingness to sign it by the patient or legally authorized patient representative (LAR) or guardian.\n9. Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088)\n\nExclusion Criteria:\n\n1. Patient is already participating in or is able to enroll in a clinical trial of GaM.\n2. Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting GaM treatment, whichever is shorter.\n3. Patients completing radiotherapy treatment less than 14 days prior to planned study treatment initiation.\n4. Patient is taking oral iron supplements or iron chelators.\n5. Current evidence of uncontrolled, significant intercurrent illness that would, in the treating physician's judgment, contraindicate the patient's treatment with GaM due to safety concerns.\n6. Patients who, in the opinion of the treating physician, have not fully recovered from recent major surgery to a sufficient extent to tolerate treatment with GaM.\n7. Known hypersensitivity to GaM or any component in its formulation.\n8. Patients taking prohibited medications as described in the current Investigator's Brochure.\n9. Patient is pregnant or actively breastfeeding","ALL","18 Years","EXPANDED_ACCESS","The objective of this program is to provide GaM for compassionate use in patients with relapsed\u002Frefractory histologic or molecular glioblastoma who have exhausted available treatments.\n\nThe population of this program is adult patients aged greater than or equal to 18 years with a diagnosis of relapsed\u002Frefractory histologic or molecular glioblastoma, according to the WHO 2021 diagnostic criteria.\n\nMolecular glioblastoma is characterized as an IDH-wildtype diffuse and astrocytic glioma in adults if there is microvascular proliferation or necrosis or TERT promoter mutation or EGFR gene amplification or +7\u002F-10 chromosome copy number changes",[21,22,23],"Glioblastoma","Refractory Glioblastoma","Glioblastoma Multiforme",[25,26],"glioblastoma","refractory glioblastoma","AVAILABLE","2026-06-04",{"date":30,"type":31},"2026-06-08","ACTUAL",{"name":33,"class":34},"Imaging Biometrics, LLC","INDUSTRY",3,{"id":37,"slug":38,"hasResults":11,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":4,"eligibilityCriteria":42,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":43,"enrollmentInfo":44,"targetDuration":4,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100607828","phase-1-b7h3il13ra2-bispecific-armored-chimeric-antigen-receptor-t-cell-therapy-study-for-recurrentrefractory-glioblastoma-100607828","NCT07193628","B7H3\u002FIL13Ra2 Bispecific Armored Chimeric Antigen Receptor T-Cell Therapy Study for Recurrent\u002FRefractory Glioblastoma","An Open-label, First-in-human, Dose-escalation and Dose-expansion, Phase I Study of Fully Human B7H3\u002FIL13Ra2 Bispecific Armored Chimeric Antigen Receptor T-Cell Therapy for Treatment of Recurrent or Refractory Glioblastoma","Inclusion Criteria:\n\n* 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.\n\n  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.\n\n  3: Karnofsky Performance Status (KPS) score ≥ 60%\n\n  4: Patients with B7H3- and\u002For IL13Ra2-positive recurrent or refractory glioblastoma confirmed by histopathology and\u002For cytology, meeting the following criteria: The positive expression rate of B7H3 \\> 30%; The positive expression rate of IL13RA2 \\> 30%; Disease progression or recurrence after standard treatment (postoperative radiotherapy combined with concurrent and adjuvant chemotherapy with temozolomide); The subject has at least one measurable lesion (based on RANO criteria, with mutually perpendicular diameters both ≥ 10mm).\n\n  5: Expected survival time ≥ 12 weeks;\n\n  6: Subjects must have adequate organ function, meeting the following laboratory test criteria: Bone Marrow Function: Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹\u002FL; Platelet Count (PLT) ≥ 100×10⁹\u002FL; Absolute Lymphocyte Count ≥ 0.3×10⁹\u002FL; Hemoglobin (HGB) ≥ 8.0 g\u002FdL. Liver function: Serum total bilirubin (T-Bil) ≤ 1.5 × upper limit of normal (ULN); for patients without liver involvement, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN; for patients with liver involvement, ALT and AST ≤ 5 × ULN; Renal function: Serum creatinine ≤ 1.6 × ULN, or creatinine clearance (Ccr) ≥ 50 mL\u002Fmin (calculated according to the Cockcroft-Gault formula); Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; Left ventricular ejection fraction \\> 50%.\n\n  7: Male subjects with reproductive potential and female subjects 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 administration of the trial drug. For female subjects of childbearing age, the pregnancy test result within ≤7 days before the administration of the trial drug must be negative.\n\nExclusion Criteria:\n\n* 1: The lesion is located in the posterior fossa structures such as the cerebellum, pons, and medulla oblongata.\n\n  2: Complicated with meningeal metastasis or detectable malignant tumor cells in cerebrospinal fluid.\n\n  3: Presence of epilepsy and\u002For high intracranial pressure that cannot be controlled or stabilized with medication.\n\n  4: Subjects 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, stroke, and any other autoimmune diseases involving the central nervous system.\n\n  5: Subjects 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 prostate cancer after radical treatment, and ductal carcinoma in situ of the breast after radical treatment.\n\n  6: Subjects who have previously received treatment targeting B7H3\u002FIL13Ra2.\n\n  7: Subjects who have previously received gene therapy or cell therapy.\n\n  8: Subjects 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.\n\n  9: Subjects who have previously received allogeneic hematopoietic stem cell transplantation; or those who are eligible for and agree to undergo autologous hematopoietic stem cell transplantation.\n\n  10: Uncontrolled active bacterial, viral, or fungal infection.\n\n  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 Heart Association \\[NYHA\\] classification ≥ III), severe arrhythmias requiring medication, as well as pulmonary, hepatic, renal, digestive system, or metabolic diseases.\n\n  12: Subjects who have received oral anticoagulant therapy within 1 week prior to CAR-T cell infusion.\n\n  13: Subjects 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 infusion or within 5 half-lives of the drug (whichever is shorter), and\u002For have not recovered from toxic reactions (recovery to CTCAE Version 5.0 grade ≤ 1) (except for alopecia; peripheral neurotoxicity with grade ≤ 2 is acceptable).\n\n  14: Subjects 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\u002Fchemotherapy can be excluded are eligible for enrollment).\n\n  15: Subjects 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 trial period.\n\n  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 virus (HCV) antibody with peripheral blood HCV RNA quantitative test result above the lower limit of detection; positive for human immunodeficiency virus (HIV) antibody; subjects with active syphilis infection.\n\n  17: Pregnant or lactating women.\n\n  18: Investigators consider that the subject has other conditions that may affect compliance or make them unsuitable for participation in this trial.","75 Years",{"count":45,"type":46},14,"ESTIMATED","INTERVENTIONAL",[49],"PHASE1","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\u002FIL13Ra2 armored Chimeric Antigen Receptor T-Cell Therapy (CAR-T) cell injection in patients with recurrent or refractory glioblastoma.\n\nApproximately 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.\n\nThis trial comprises two phases: the first phase is the dose-escalation phase, and the second phase is the dose-expansion phase.",[22,52],"Recurrent Glioblastoma",[26,54,55,56,57],"recurrent glioblastoma","Immunotherapy, Adoptive","Receptors, Chimeric Antigen","Interleukin-13 Receptor alpha2 Subunit","RECRUITING","2025-11-17",{"date":61,"type":31},"2025-11-18",{"date":63,"type":31},"2025-09-26",{"date":65,"type":46},"2028-12-31",{"name":67,"class":68},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",1]