CAR-T Cell Immunotherapy, GD2 Positive Glioma
Conditions
Keywords
CAR-T cell immunotherapy, GD2, glioma
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in treating with GD2 positive 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 GD2 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 safety and effectiveness of CAR-T cell immunotherapy in treating with GD2 positive glioma patients.
Interventions
BIOLOGICALCAR-T cell immunotherapy
This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GD2 antigen.
Sponsors
Fuda Cancer Hospital, Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The primary GD2 positive patients, the best are glioma patients. 2. The recurrent GD2 positive patients, the best are glioma patients. 3. 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/mm3. * Platelet count greater than 100,000/mm3. * 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. 4. 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. 5. Patients must be willing to sign an informed consent.
Exclusion criteria
1. The patients with multiple kinds of cancers are excluded. 2. 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. 3. Patients with any of the following 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. 4. Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded. 5. Pregnant and/or lactating women will be excluded. 6. Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors. 7. Patients with any type of primary immunodeficiencies will be excluded from the study. 8. Patients requiring corticosteroids (other than inhaled) will be excluded. 9. Patients with history of T cell tumors will be excluded. 10. Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effectiveness of CAR-T cell immunotherapy | 3 months | It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST） |
Secondary
| Measure | Time frame |
|---|---|
| Progress free survival（PFS） | 1 year |
Other
| Measure | Time frame |
|---|---|
| Overall survival（OS） | 3 years |
Countries
China
Outcome results
None listed