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|NCT02575261 : CAR-T Cell Immunotherapy for EphA2 Positive Malignant Glioma Patients|
|Phase||Phase 1/Phase 2|
|Ages||Min: 18 Years Max: 80 Years|
1. the primary EphA2 positive patients, the best are malignant glioma patients.
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
- Patients must be willing to sign an informed consent.
1. the patients with multiple kinds of cancars 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 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
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.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02575261
| Link to official Clinicaltrials.gov listing