Status:
WITHDRAWN
CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients
Lead Sponsor:
Fuda Cancer Hospital, Guangzhou
Conditions:
GD2 Positive Glioma
CAR-T Cell Immunotherapy
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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 co...
Eligibility Criteria
Inclusion
- The primary GD2 positive patients, the best are glioma patients.
- The recurrent GD2 positive patients, the best are 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/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.
- 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.
- Patients must be willing to sign an informed consent.
Exclusion
- The patients with multiple kinds of cancers 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 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.
- 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.
Key Trial Info
Start Date :
October 15 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03252171
Start Date
October 15 2015
End Date
August 15 2016
Last Update
July 16 2020
Active Locations (1)
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1
Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, China, 510000