Phase
Condition
Gliomas
Astrocytoma
Treatment
B7-H3-targeting CAR-T cells
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 theimmunochemical 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 effectivecontraception;
Exclusion
Exclusion Criteria:
Pregnant or breastfeeding females;
Contraindication to bevacizumab;
Within 5 days before the CAR-T cell infusion, subjects receiving systemicadministration of steroids with dosage more than 10mg/d prednisone or the equivalentdoses of other steroids ( not including inhaled corticosteroid);
Comorbid with Other uncontrolled malignancy;
Active immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus ortuberculosis infection;
Subjects receiving the placement of a carmustine slow-release wafer within 6 monthsbefore the enrollment;
Autoimmune diseases;
Receiving long-term immunosuppressive treatment after organ transplantation;
Severe or uncontrolled psychiatric diseases or condition that could increase adverseevents or interfere the evaluation of outcomes;
Not recovered from the toxicities or side effects by previous treatment;
Subjects who have participated the other interventional trial within one monthbefore the enrollment, or have received other CAR-T cell therapies or gene-modifiedcell therapy before enrollment.
Subjects with medical conditions that affect signing the written informed consent orcomplying with the research procedures, the medical conditions including, but notlimited to cardio-cerebral vascular diseases, renal dysfunction/failure, pulmonaryembolism, coagulation disorders, active systemic infection, uncontrolled infectionet. al; or patients who are unwilling or unable to comply with the researchprocedures; these
Subjects with other conditions that would interfere trial participation at theinvestigator's discretion.
Study Design
Connect with a study center
Beijing Tiantan Hospital
Beijing, Beijing 100730
ChinaSite Not Available
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