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| Name | Class |
|---|---|
| Beijing Mario Biotech Company | UNKNOWN |
| Hebei Senlang BIotech Company | UNKNOWN |
| Beijing HuiNengAn Biotech Company | UNKNOWN |
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A pilot study to determine the safety and efficacy of chimeric antigen receptor T cell (autologous T cells transduced with a lentiviral vector expressing chimeric antigen receptor with or without anti-PDL1 antibody) personalized immunotherapy for patients with recurrent malignant gliomas based on the expression of tumor specific/associated antigens (EGFRVIII, IL13Rα2, Her-2, EphA2, CD133, GD2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biological: Chimeric antigen receptor T cells | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chimeric antigen receptor T cells | Biological | chimeric antigen receptor T cells expressing receptors specific for EGFRvIII, IL13Rα2, Her-2, CD133, EphA2, GD2, respectively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events attributed to the administration of the chimeric antigen receptor T cells | Determine the toxicity profile of the chimeric antigen receptor T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline. | 1 year |
| clinical activity of chimeric antigen receptor T cells |
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Inclusion Criteria:
Voluntary informed consent for entry of trial;
Age greater than 18 years, and less than 70 years;
Pathologically confirmed recurrent malignant gliomas;
Tumor cells from resected tissue must be available for antigen testing (EGFRvIII, IL13Rα2, Her-2, CD133, EphA2, GD2) and at least one of the targets should be tested positively by immunohistochemistry study;
If the patient is on dexamethasone, the anticipated dose must be 4 mg/day or less for at least 5 days prior to apheresis.
Patients must have a Karnofsky performance status of greater than or equal to 70.
Life expectancy greater than 3 months;
Participants with adequate organ function as measured by:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital | Recruiting | Beijing | 100054 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34235085 | Derived | Lin Q, Ba T, Ho J, Chen D, Cheng Y, Wang L, Xu G, Xu L, Zhou Y, Wei Y, Li J, Ling F. First-in-Human Trial of EphA2-Redirected CAR T-Cells in Patients With Recurrent Glioblastoma: A Preliminary Report of Three Cases at the Starting Dose. Front Oncol. 2021 Jun 21;11:694941. doi: 10.3389/fonc.2021.694941. eCollection 2021. |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D012008 | Recurrence |
| 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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the number of infused chimeric antigen receptor T cells; |
| 28 days |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |