r/r B-ALL
Conditions
Interventions
Case series:CD19CART
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 60 Years
Inclusion criteria
Inclusion criteria: 1. Flow cytometry results for patients with CD19 +; 2. peripheral blood CD3-positive cells count 5%, extramedullary recurrence or molecular biology recurrence; (2) Previously treated with less than complete remission of at least 2 chemotherapy regimens (rituximab excluding monotherapy); (3) last chemotherapy and disease progression less than 1 year interval; 4. Not suitable for allogeneic stem cell transplantation conditions or due to conditions to abandon transplantation allogeneic stem cell transplantation; 5. patients who have relapsed after stem cell transplantation; 6. Aged =60 years old; 7. Expected survival> 6 months; 8. If the subject is a woman of childbearing age, the pregnancy test is negative prior to the start of administration and agree to take effective contraception until the last follow-up during the study period; 9. Those who volunteered to participate in the study and who signed the informed consent by themselves or their authorized representatives.
Exclusion criteria
Exclusion criteria: Patients with any of the following exclusion criteria should not be enrolled in this study: 1) have a history of epilepsy or other central nervous system diseases; 2) have graft-versus-host response, require the use of immunosuppressive agents; 3) There are clinically relevant cardiovascular conditions such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months prior to screening, or any grade 3 (moderate) or 4 cardiac function Severe) heart disease (NYHA according to New York Heart Association functional classification); 4) Pregnant or lactating women (the safety of this therapy for unborn children is unknown); 5) not cured of active infection; 6) active hepatitis B or hepatitis C virus infection; 7) Those who have combined systemic steroid medications within 2 weeks prior to treatment (except for the most recent or currently currently used inhaled steroid); 8) Any gene therapy product previously used; Creatinine> 2.5 mg/dl (221.0 umol/L) or ALT / AST> 3 times normal or bilirubin> 2.0 mg / dl (34.2 umol / L); 9) have other uncontrolled diseases, which the researcher thinks are not suitable for the participants; 10) people living with HIV; 11) Leukemia patients with central nervous system involvement (CNS); 12) Anything the investigator believes may increase the subject's risk or interfere with the findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tumor burden in bone marrow; | — |
Countries
China
Contacts
Public ContactXiaoyan Ke
Peking University Third Hospital
Outcome results
None listed