DLL3 CAR-T Therapy Targeting Brain Tumors

Korábbi kezelés

• a prior history of gliadel implantation 4 weeks before this study start or currently receiving antibody based therapies;

Más betegség

• HIV positive;
• tuberculosis infection not under control;
• history of autoimmune disease, or other diseases require long-term administration of steroids or immunosuppressive therapies;
• history of allergic disease, or allergy to immune cells or study product excipients;

Egyéb

• patients already actively enrolled in other immune cell clinical study; patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

• abilities to understand and the willingness to provide written informed consent;
• patients are ≥ 2 and ≤ 70 years old;
• recurrent or refractory brain tumor patients with measurable lesions. Patients have received standard care of medication, such as gross total resection with concurrent radio-chemotherapy (~54 - 60 Gy, TMZ). Patients must either not be receiving dexamethasone or receiving ≤ 4 mg/day at the time of leukopheresis;
• Karnofsky performance score (KPS) ≥ 60;
• life expectancy >3 months;
• satisfactory bone marrow, liver and kidney functions as defined by the following: absolute neutrophile count ≥ 1500/mm\^3; hemoglobin > 10 g/dL; platelets > 100000 /mm\^3; Bilirubin < 1.5×ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5×ULN; creatinine < 1.5×ULN;
• peripheral blood absolute lymphocyte count must be above 0.8×10\^9/L;
• satisfactory heart functions;
• patients must be willing to follow the instructions of doctors;
• women of reproductive potential (between 15 and 49 years old) must have a negative pregnancy test within 7 days of study start. Male and female patients of reproductive potential must agree to use birth control during the study and 3 months post study.