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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental:CAR-T cell immunotherapy | Experimental | Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EphA2 antigen by infusion. |
|
| No Intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR-T cell immunotherapy | Biological | This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EphA2 antigen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effectiveness of CAR-T cell immunotherapy | 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of CAR-T cell immunotherapy (adverse events) | After CAR-T cell infusion,we will observe the potential adverse events related to the T-cell infusion such as high fever,jaundice, kidney failure and so on. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response | Clinical response to T-cell infusion, especially change of tumor volume will be evaluated by comparing disease identified by computed tomography, magnetic resonance imaging, and/or positron emission tomography images. | 24 weeks |
| Progress free disease (PFS) |
Inclusion Criteria:
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).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lizhi Niu, PhD | Fuda Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central laboratory in Fuda cancer hospital | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
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| 1 year |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |