Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma

Korábbi kezelés

• Contraindication to bevacizumab；
• Within 5 days before the CAR-T cell infusion, subjects receiving systemic administration of steroids with dosage more than 10mg/d prednisone or the equivalent doses of other steroids ( not including inhaled corticosteroid)；
• Subjects receiving the placement of a carmustine slow-release wafer within 6 months before the enrollment;
• Receiving long-term immunosuppressive treatment after organ transplantation;
• Not recovered from the toxicities or side effects by previous treatment;
• Subjects who have participated the other interventional trial within one month before the enrollment, or have received other CAR-T cell therapies or gene-modified cell therapy before enrollment.

Más betegség

• Comorbid with Other uncontrolled malignancy；
• Active immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus or tuberculosis infection;
• Autoimmune diseases;
• Severe or uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes;
• Subjects with medical conditions that affect signing the written informed consent or complying with the research procedures, the medical conditions including, but not limited to cardio-cerebral vascular diseases, renal dysfunction/failure, pulmonary embolism, coagulation disorders, active systemic infection, uncontrolled infection et. al; or patients who are unwilling or unable to comply with the research procedures; these
• Subjects with other conditions that would interfere trial participation at the investigator's discretion.

Egyéb

• Pregnant or breastfeeding females；

• Male or female, aged 18-75 years (including 18 and 75 years old)；
• Patients with relapsed glioblastoma, as confirmed by positron emission tomography (PET) or histologic pathology；
• A >= 30% staining extent of B7-H3 in his/her primary/recurrent tumor tissue by the immunochemical method;
• Karnofsky scale score>=50
• Availability in collecting peripheral blood mononuclear cells (PBMCs) ；
• Adequate laboratory values and adequate organ function;
• Patients with childbearing/fathering potential must agree to use highly effective contraception；