CAR-T Cell Immunotherapy for EphA2 Positive Malignant Glioma Patients
NCT ID: NCT02575261
Last Updated: 2020-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2015-09-30
2016-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental:CAR-T cell immunotherapy
Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EphA2 antigen by infusion.
CAR-T cell immunotherapy
This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EphA2 antigen.
No Intervention
No interventions assigned to this group
Interventions
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CAR-T cell immunotherapy
This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EphA2 antigen.
Eligibility Criteria
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Inclusion Criteria
2. the recurrent EphA2 positive patients, the best are malignant 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.
* 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 Criteria
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 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.
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.
18 Years
80 Years
ALL
No
Sponsors
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Fuda Cancer Hospital, Guangzhou
OTHER
Responsible Party
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Principal Investigators
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Lizhi Niu, PhD
Role: STUDY_CHAIR
Fuda Cancer Hospital
Locations
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Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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CAR-T for malignant glioma
Identifier Type: -
Identifier Source: org_study_id
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