Status:
UNKNOWN
Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas
Lead Sponsor:
Xuanwu Hospital, Beijing
Collaborating Sponsors:
Beijing Mario Biotech Company
Hebei Senlang BIotech Company
Conditions:
Glioma
Malignant Glioma of Brain
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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
- Serum creatinine less than or equal to 1.5 x upper limit of normal
- 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
- Female subjects of reproductive potential who are pregnant or lactating;
- 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;
Key Trial Info
Start Date :
March 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03423992
Start Date
March 2 2018
End Date
January 30 2023
Last Update
June 15 2021
Active Locations (1)
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1
Xuanwu Hospital
Beijing, China, 100054