Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma (NCT05241392) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma
China30 participantsStarted 2022-01-27
Plain-language summary
This is an open, single-arm, dose-escalation and multiple-dose study to evaluate the safety, tolerability and preliminary effectiveness of B7-H3-targeting Chimeric Antigen Receptor-T (CAR-T) cell therapy on patients with recurrent glioblastomas. The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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；
Exclusion criteria
✕. Pregnant or breastfeeding females；
✕. 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)；
✕. Comorbid with Other uncontrolled malignancy；
✕. Active immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus or tuberculosis infection;