Malignant glioma
Conditions
Interventions
QH104 cell therapy:Intraventricular injection of QH104 cells
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
4 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age >= 4 years old, gender not limited; 2) Have malignant glioma confirmed by histology or cytology, and positive expression of B7-H3; 3) KPS>= 60; 4) Basically normal bone marrow reserve function and normal liver and kidney functions (laboratory tests must be met before the first treatment with QH104 cell preparations) : The absolute value of neutrophils is >= 1,500/mm3; Hemoglobin > 10g/dL; Platelet count > 100,000/mm3; Alanine aminotransferase/aspartate aminotransferase 55%; 7) Suitable for Ommaya capsule infusion; 8) No bleeding or coagulation dysfunction diseases; 9) Pregnancy tests for women of childbearing age should be negative, and both men and women agree to use effective contraceptive measures during the treatment and within one year thereafter; 10) Sign the informed consent form for the trial.
Exclusion criteria
Exclusion criteria: 1) Received directional irradiation of the central nervous system within 7 days before the first infusion of QH104; 2) Uncontrolled complications, including but not limited to: persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia or mental illness/social conditions, which may limit patients' compliance with the study requirements; 3) Suffering from a known mental illness or substance abuse disorder may affect compliance with the requirements of the trial; 4) Currently undergoing treatment with any other research drugs; 5) Diagnosed with immunodeficiency disease; 6) Suffering from active infections that require systematic treatment; 7) Patients with a history of organ transplantation; 8) Magnetic resonance imaging (MRI) examination cannot be performed; 9) Severe cardiovascular damage: A history of New York Heart Association (NYHA) grade II or above congestive heart failure, unstable angina pectoris, myocardial infarction or stroke within 6 months after the first medication, or arrhythmia requiring treatment during screening; 10) Allergy to immunotherapy and related cells; 11) Received CAR-T immunocell therapy in the early stage; 12) Have participated in other clinical trials within the past 30 days;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Validity; | — |
Countries
China
Contacts
Public ContactTao Sun
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed