Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma
Study of Anti-CD19 Chimeric Antigen Receptor T Cells（PZ01） for Relapsed/ Refractory B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma
Lead SponsorPinze Lifetechnology Co. Ltd.
Indication/ConditionB-cell Lymphoma B-cell Acute Lymphoblastic Leukemia
Intervention/TreatmentPZ01 CAR-T cells
The major aim of this research is to assess the feasibility, safety and effectiveness of CD19 CAR-T Cell Therapy for Relapsed/ Refractory Acute Lymphoblastic Leukemia/ B cell Lymphoma patients who have applied it.
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and 4-1BB. Autologous T cells will be gene-engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
This is a phase I study. Patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma are eligible for enrollment.
Inclusion Criteria: Subjects or their legal guardians participate in this experiment voluntarily and informed consent form must be signed In accordance with National Comprehensive Cancer Network (NCCN) ALL Guidelines for Patients (2016, v.1) and CD19+B-ALL/B cell lymphoma patients diagnosed by histology In accordance with r/r CD19+ B-ALL/B cell lymphoma diagnosis, including any of the following situations: Getting through 2 treatments of standard chemotherapy with CR not yet obtained Reach CR for the first inducement, but CR lasts for ≦12 months r/r CD19+ B-ALL/B cell lymphoma for no positive effect after first or repeated remedial treatment ≧2 times of recurrence Remedial chemotherapy is not used within 4 weeks before cell therapy Immunosuppressive drug is not used within 4 weeks before cell therapy, including but not limited to systemic hormone therapy Antibody drug treatment is not received within 2 weeks before cell therapy Normal cardiac motion shown by echocardiography, left ventricular ejection fraction (LVEF) ≥50%, with no pericardial effusion and severe symptoms of cardiac arrhythmia No pulmonary active infection is found, with normal pulmonary function and indoor air SaO2 ≧92% No contraindications for leukapheresis Expected survival >3 months Grade 0 or 1 of ECOG performance status Exclusion Criteria: Pregnant and breastfeeding women Uncontrolled active infection Uncontrolled infectious disease is diagnosed, such as HIV, syphilis, hepatitis A, hepatitis B, hepatitis C and E. Patients who have used a large amount of glucocorticoid or other immunosuppressive drugs within 4 weeks Stage II-IV Acute/chronic general graft versus host disease Gene therapy has been undergone in the past