Chimeric Antigen Receptor-Modified T Cells for EphA2 Positive Recurrent and Metastatic Malignant Glioma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- EphA2 Positive Malignant Glioma
- Sponsor
- Fuda Cancer Hospital, Guangzhou
- Locations
- 1
- Primary Endpoint
- The effectiveness of CAR-T cell immunotherapy
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in treating with EphA2 positive malignant glioma patients.
Detailed Description
Chimeric antigen receptor (CAR) is a recombinant receptor with both antigen-binding and T cell activating functions. Chimeric antigen receptor T cell Immunotherapy has more advantages compared with conventional immunotherapy, especially in dealing with patients of hematologic malignancies and solid malignant tumors.This study design a novel specific Chimeric antigen receptor aiming at EphA2 antigen.After CAR-T cell infusion,At periodic intervals, the investigators will evaluate clinical symptoms Improved conditions of this disease.Through this study,the investigators will evaluate the safty and effectiveness of CAR-T cell immunotherapy in treating with EphA2 positive malignant glioma patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •the primary EphA2 positive patients, the best are malignant glioma patients.
- •the recurrent EphA2 positive patients, the best are malignant glioma patients.
- •Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:
- •Absolute neutrophil count greater than 1500/mm
- •Platelet count greater than 100,000/mm
- •Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter).
- •Total bilirubin \< 1.5 times upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2).
- •Seronegative for HIV antibody.
- •Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.
- •Patients must be willing to practice birth control during and for four months following treatment.NOTE:women of child-bearing age must have evidence of negative pregnancy test.
Exclusion Criteria
- •the patients with multiple kinds of cancars are excluded.
- •Patients with uncontrolled hypertension (\> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.
- •Patients with any of the follo wing pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), \< 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) \< 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.
- •Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.
- •Pregnant and/or lactating women will be excluded.
- •Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.
- •Patients with any type of primary immunodeficiencies will be excluded from the study.
- •Patients requiring corticosteroids (other than inhaled) will be excluded.
- •Patients with history of T cell tumors will be excluded.
- •Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
Outcomes
Primary Outcomes
The effectiveness of CAR-T cell immunotherapy
Time Frame: 24 weeks
After CAR-T cell infusion,we will detect the persistence of CAR-T cells by flow-cytometric analysis.And we will observe if this CAR T cells can significantly inhibite the tumor growth by discovering the change of tumor volume.
Secondary Outcomes
- The safety of CAR-T cell immunotherapy (adverse events)(6 weeks)