Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas
NCT ID: NCT03423992
Last Updated: 2021-06-15
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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UNKNOWN
PHASE1
100 participants
INTERVENTIONAL
2018-03-02
2023-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Biological: Chimeric antigen receptor T cells
chimeric antigen receptor T cells
chimeric antigen receptor T cells expressing receptors specific for EGFRvIII, IL13Rα2, Her-2, CD133, EphA2, GD2, respectively
Interventions
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chimeric antigen receptor T cells
chimeric antigen receptor T cells expressing receptors specific for EGFRvIII, IL13Rα2, Her-2, CD133, EphA2, GD2, respectively
Eligibility Criteria
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Inclusion Criteria
* 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:
1. White blood count greater than or equal to 2500/mm\^3; platelets greater than or equal to 100,000/mm\^3, hemoglobin greater than or equal to 10.0 g/dL; without transfusion or growth factor support
2. Aspartate transaminase (AST), Alanine transaminase (ALT), gamma glutamyl transpeptidase (GGT), lactic acid dehydrogenase (LDH), alkaline phosphatase within 2.5 x upper normal limit, and total bilirubin less than or equal to 2.0 mg/dL
3. Serum creatinine less than or equal to 1.5 x upper limit of normal
4. Coagulation tests prothrombin time (PT) and partial thromboplastin time (PTT) have to be within normal limits, unless the patient has been therapeutically anti-coagulated for previous venous thrombosis.
Exclusion Criteria
* Previous treatment with any gene therapy products or other form immunotherapy;
* Uncontrolled active infection.
* Active or latent chronic hepatitis B \[detectable hepatitis B surface antigen (HBsAg)\] or active hepatitis C (positive serology \[hepatitis C virus Ab\]) infection.
* HIV infection;
* History of allergy or hypersensitivity to study product excipients (human serum albumin, Dimethyl sulfoxide, and Dextran 40);
* Currently enrolled in other clinical trials;
18 Years
70 Years
ALL
No
Sponsors
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Beijing Mario Biotech Company
UNKNOWN
Hebei Senlang BIotech Company
UNKNOWN
Beijing HuiNengAn Biotech Company
UNKNOWN
Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Qingtang Lin
Associate Professor, Department of Neurosurgery
Locations
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Xuanwu Hospital
Beijing, , China
Countries
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Facility Contacts
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References
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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.
Other Identifiers
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Xuanwu hospital
Identifier Type: -
Identifier Source: org_study_id
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