Recurrent primary intracranial malignant tumor
Conditions
Interventions
Y-1 injection:Single dose administration: The subject receives a single infusion of the corresponding drug in the morning of the day of administration. Multiple doses are administered: during a contin
Sponsors
Beijing Tiantan Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) The patient voluntarily joined this study and signed an informed consent form (ICF); 2) Age = 18 years old, regardless of gender; For subjects over 70 years old, they need to be able to take care of themselves in daily life, with an expected survival period of = 6 months, and the researcher determines that they are suitable to participate in this study before being included; 3) The pathological diagnosis of the patient is recurrent primary intracranial malignant tumor, including but not limited to malignant glioma, meningioma, chordoma, etc, And at least one measurable tumor lesion (defined as a well-defined enhancement lesion on MRI according to the RANO standard, capable of developing on more than 2 axial films with a layer thickness of 5 mm, with mutually perpendicular diameters greater than 10 mm, and can be accurately measured repeatedly. If the scanning layer thickness is large, the minimum measurable lesion should be greater than 2 times the layer thickness); 4) Patients who have failed or are unable to tolerate standard treatment; 5) If the patient has received radiotherapy and the interval between the last radiotherapy is = 3 months; 6) If the patient has received chemotherapy and the time interval between the last chemotherapy is = 4 weeks, with a time interval of = 6 weeks for nitrosourea drugs; 7) The expected survival period is not less than 12 weeks; 8) KPS score = 60; 9) The patient must undergo a laboratory examination within 14 days before the first dose of the study drug, and the laboratory examination indicators meet the following standards: a) Platelet (PLT) = 100 × 10^9/L; b) Absolute neutrophil count (ANC) = 1.5 × 10^9/L; c) Absolute white blood cell count (WBC) = 3.0 × 10^9/L and = 15 × 10^9/L; d) Hemoglobin (Hgb) = 90 g/L (no blood transfusion or use of erythropoietin within 4 weeks); e) Total bilirubin = 1.5 times the upper limit of normal value (ULN); f) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 times ULN; g) Cr = 1.0 times ULN, endogenous creatinine clearance rate = 50 mL/min (calculated according to Cockcroft Fault formula).
Exclusion criteria
Exclusion criteria: 1) Clearly identify individuals who have previously been allergic to this product or any of its excipients (ethanol, propylene glycol, cysteine hydrochloride); 2) Except for primary intracranial malignant tumors, the patient had other malignant tumors (excluding fully treated cervical carcinoma in situ, skin squamous cell carcinoma, and well controlled localized basal cell skin cancer) within the first 5 years of enrollment. However, if you have previously suffered from malignant tumors and have not experienced disease recurrence for more than 5 years, you can still participate in this study; 3) Perform major surgical procedures within 4 weeks prior to the start of the study (excluding intracranial malignant tumor resection and diagnostic surgical procedures. If it is an intracranial tumor surgery, it is required to have a time interval of = 2 weeks from the last resection before participating in this study); 4) Patients who cannot undergo enhanced MRI examination; 5) The toxicity related to previous cancer treatment has not yet recovered to CTCAE 5.0 level evaluation = 1 level (excluding toxicity judged by researchers to have no safety risk such as hair loss); 6) Patients who have severe laboratory test abnormalities and are determined by researchers to be unsuitable for enrollment; 7) Previously known severe abnormalities in blood, lung, liver, and kidney function; 8) The patient is HBsAg positive and the peripheral blood HBV DNA titer test is = the upper limit of the normal value of the research center; Hepatitis C virus infection is defined as HCV antibody positive and HCV RNA positive; 9) Having a history of immunodeficiency, including HIV testing positive, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation, and a history of severe autoimmune diseases that the researcher determines are not suitable for enrollment; 10) Patients who test positive for syphilis and are in the active phase are defined as TP positive and PRP positive; 11) Patients who have received high-dose systemic hormone therapy (dexamethasone>5mg/day or equivalent doses of other hormones) within 14 days prior to the first use of the study drug, except for the following situations: treatment with topical, ocular, intra-articular, nasal, and inhaled corticosteroids; Short term use of glucocorticoids for preventive treatment (such as prevention of contrast agent allergies); 12) The subject has clinical symptoms or diseases of heart or cerebrovascular disease that cannot be well controlled, including but not limited to a) NYHA grade II or above heart failure or left ventricular ejection fraction (LVEF)<50%; b) The QT interval (QTcF) corrected by the Fridericia method is = 450 ms for males and = 470 ms for females (if the first test result meets the exclusion criteria, the mean corrected by three tests can be used for judgment); c) Unstable angina pectoris; d) Have experienced myocardial infarction and cerebral infarction within 6 months; e) Clinically significant supraventricular or ventricular arrhythmias that remain poorly controlled without or after clinical intervention; 13) Previously known abnormalities in coagulation function, active bleeding, or severe thrombotic disease; 14) Has a clear history of mental disorders, such as schizophrenia, in the past; 15) Previous history of drug abuse and dependence (including morphine, tetrahydrocannabinoid acid, methamphetamine, dimethylenedioxyamphetamine, k
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events and reactions;Adverse events refer to all adverse events (AE) and serious adverse events (SAE);Physical examination;vital signs;12-lead ecg;Blood routine;blood biochemical;Urinalysis;coagulation;clinical symptoms; | — |
Countries
China
Contacts
Public ContactLi Wenbin
Beijing Tiantan Hospital Affiliated to Capital Medical University
Outcome results
None listed