Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas

Capital Medical University

Status and phase

Unknown

Phase 1

Conditions

Glioma

Recurrence Tumor

Malignant Glioma of Brain

Treatments

Biological: chimeric antigen receptor T cells

Study type

Interventional

Funder types

Other

Identifiers

NCT03423992

Xuanwu hospital

Details and patient eligibility

About

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).

Enrollment

100 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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:
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

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;