relapsed or refractory CD19+ B cell leukemia
Conditions
Interventions
A:anti-CD19-CAR-T cells
Sponsors
Shanghai Changhai Hospital,The Second Military Medical University
Eligibility
Sex/Gender
All
Age
1 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) CD19+ B-cell leukemia; 2) Age > 18 years; 3) Expected survival > 12 weeks; 4) Creatinine < 2.5 mg/dl; 5) ALT/AST < 3* normal; 6) Bilirubin <2.0 mg/dl; 7) Sucessful test expansion of T-cells; 8) Adequate venous access for apheresis, and no other contraindications for leukapheresis; 9) Voluntary informed consent is given.
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating women; 2) Uncontrolled active infection; 3) Active hepatitis B or hepatitis C infection; 4) Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary; 5) Previously treatment with any gene therapy products; 6) Feasibility assessment during screening demonstrates<30% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation; 7) Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, CNS diseases).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cytokines IL-1beta;cytokine IL-2R;cytokine IL-6;cytokine IL-8;cytokine IL-10;cytokine TNF-alpha;CRP protein;copy number of CART in vivo;erythrocyte sedimentation rate; | — |
Countries
China
Contacts
Public ContactJianmin Yang
Outcome results
None listed