Clinical Trial Details
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NCT03423992 : Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas
PhasePhase 1
AgesMin: 18 Years Max: 70 Years
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,
IL13Ra2, 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

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:

- 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;
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