Humanized CAR-T Therapy for Treatment of B Cell Malignancy
Humanized CAR-T Therapy for Treatment of B Cell Malignancy
The present study evaluates the safety and efficacy of humanized Chimeric antigen receptor T
 cells (CAR-T) in treating recurrent or refractory B cell malignancy targeting CD19 with a
 humanized scFv. All participants will receive autologous chimeric antigen receptor engineered
 T cells.
CD19 has been extensively evaluated as a therapeutic target for recurrent or refractory B
 cell malignancy by chimeric antigen receptor T cell therapy, the single chain antibody
 sequence (scFv) against CD19 derived from a mouse hybridoma was widely employed. However, the
 immunogenicity of the mouse scFv sequence might be one of the reasons that CAR-T cells cannot
 persist in vivo for long. In present study investigators replace the mouse-derived scFv with
 a a humanized one and evaluate its safety and efficacy.
Inclusion Criteria:

 -  Age≥3 at the time of consent

 -  Survival time>12 weeks

 -  B cell hematological malignancies by pathological examination

 -  Chemotherapy failure or recurrent B cell malignancy

 -  Creatinine< 2.5mg/dl

 -  Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal
 level

 -  Karnofsky Performance Status>50% at the time of screening

 -  Bilirubin<2.0mg/dl

 -  Adequate pulmonary, renal, hepatic, and cardiac function

 -  Fail in autologous or allogenic haemopoietic stem cell transplantation

 -  Free of leukocytes removal contraindications

 Exclusion Criteria:

 -  Pregnant or nursing women

 -  Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV)
 infection at the time of screening

 -  Previous treatment with any gene therapy product

 -  Abnormal vital signs

 -  Highly allergic constitution or history of severe allergies, especially allergy to
 interleukin-2

 -  General infection or local severe infection, or other infection that is not controlled

 -  Dysfunction in lung, heart, kidney and brain.

 -  Severe autoimmune diseases

 -  other symptoms that are not applicable for CAR-T