CD19 CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia
B Cell Lymphoma, B-cell Acute Lymphoblastic Leukemia
About this trial
This is an interventional treatment trial for B Cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Patients or their legal guardians voluntarily participate and sign the Informed Consent Document;
- 18 Years and older, Male and female;
- Pathologically and histologically confirmed CD19 + B cell tumors; Patients currently have no effective treatment options, such as chemotherapy or relapse after hematopoietic stem cell transplantation; Or patients voluntarily choose transfusion of anti-CD19 CAR-T cells as the first treatment program;
B-cell tumors / lymphomas and B-cell acute lymphoblastic leukemia include the following four types:
- B-cell acute lymphoblastic leukemia;
- Indolent B-cell lymphomas;
- Aggressive B-cell lymphoma; 4、 Subjects:
(1) Residual lesions remain after treatment; (2) Not suitable for Hematopoietic stem cell transplantation (auto/allo-HSCT); (3) Relapse after Complement receptor 1 (CR1) and unsuitable for HSCT; (4) Patients with high risk factors; (5) Relapse or no remission after hematopoietic stem cell transplantation or cell immunotherapy.
5、 Have measurable or evaluable tumor foci; 6、 Liver, kidney and cardiopulmonary functions meet the following requirements:
- Serum glutamic pyruvic transaminase (ALT) and serum glutamic oxaloacetic transaminase (AST) <3 ×upper limit of normal (ULN);
- Total bilirubin ≤34.2μmol/L;
- Serum creatinine<220μmol/L;
- Baseline oxygen saturation≥95%;
- Left ventricular ejection fraction(LVEF)≥40%. 7、 Subjects who did not receive Chemotherapy, Radiotherapy, Immunotherapy (immunosuppressive drugs) or other treatment within 4 weeks prior to enrollment; Relevant toxicity≤1 grade before enrollment (except for low toxicity such as hair loss); 8、Peripheral superficial venous blood flow is smooth, which can meet the needs of intravenous drip; 9、Clinical performance status of eastern cancer cooperation group (ECOG) score ≤2,Expected survival≥3 months;
Exclusion Criteria:
- Pregnant (urine/blood pregnancy test positive) or lactating women;
- Planned pregnancy during treatment or within 1 year after treatment, or a male subject whose partner plans pregnancy within 1 year of their cell transfusion;
- Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 year after enrollment;
- Active or uncontrollable infection within four weeks prior to enrollment;
- Patients with active hepatitis B/C;
- HIV-infected patients;
- Severe autoimmune or immunodeficiency disorders;
- Patients are allergic to macromolecule drugs such as antigens or cytokines;
- Subjects participated in other clinical trials within 6 weeks before enrollment;
- Systematic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones);
- Mental illness;
- Drug abuse/addiction;
- The investigators consider other conditions unsuitable for enrollment.
Sites / Locations
- Kunming Yan'an Hospital, Oncology DepartmentRecruiting
Arms of the Study
Arm 1
Experimental
Anti-CD19 CAR-T Cells Injection
Dosage form:injection Dosage:1-5x10^6/kg, 70ml/time, The CAR-T cells will be administered by i.v. injection over 20-30 minutes Frequency: total one time