Status:
ACTIVE_NOT_RECRUITING
Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Glioblastoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 ther...
Eligibility Criteria
Inclusion
- 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
- 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;
- Subjects receiving the placement of a carmustine slow-release wafer within 6 months before the enrollment;
- Autoimmune diseases;
- Receiving long-term immunosuppressive treatment after organ transplantation;
- Severe or uncontrolled psychiatric diseases or condition that could increase adverse events 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 month before the enrollment, or have received other CAR-T cell therapies or gene-modified cell therapy before enrollment.
- 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.
Key Trial Info
Start Date :
January 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05241392
Start Date
January 27 2022
End Date
December 31 2026
Last Update
February 11 2025
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100730