refractory/relapsed B cell malignancies
Conditions
Interventions
Case series:CART-19 cell
Sponsors
Department of Hematology, Luoyang Central Hospital
Eligibility
Sex/Gender
All
Age
4 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 4 to 70 years, with a life expectancy of more than 3 months; 2. diagnosed as b-lineage acute lymphoblastic leukemia; 3. KPS score >70 points; ZPS score =2; 4. there is no effective treatment after the failure of transplantation of autologous stem cells or allogeneic stem cells, or recurrence after chemotherapy; 5. sufficient heart, liver, kidney, bone marrow function (heart: no heart disease or coronary heart disease, cardiac function: 1-2 level; Liver: total bilirubin is no more than 3 times normal value upper limit (ULN), aspartate aminotransferase (AST) is less than or equal ALT no more than 2.5 times normal value upper limit; Kidney: Cr = 1.25 times normal value upper limit; Bone marrow: WBC is greater than or equal to 3.0 * 109/L, Hb is greater than 90 g/L, and PLT is greater than 80 * 10^9/L; 6. patients and family members agree to participate in the clinical study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) pregnant or lactating women (women of childbearing age need to have a pregnancy test); 2) serious infectious diseases or viral diseases (HIV positive, syphilis, etc.); 3) active b or c viral hepatitis; 4) patients who had been treated witha large amount of glucocorticoid or other immunosuppressive agents within 4 weeks; 5) patients with serious heart, liver, renal insufficiency, diabetes and other diseases; 6) transaminase > 2.5 times normal value upper limit, bilirubin > 3 times normal value upper limit, creatinine > 1.25 times normal value upper limit; 7) participated in other clinical studies in the past 3 months, or treated by other gene products; 8) unfit for the study, or other situations that may affect the analysis of the results of this clinical study; 9) severe allergies; 10) severe allergic constitution; 11) with other serious diseases (such as autoimmune diseases, immune deficiency and organ transplantation) that conflict with the programme; 12) with history of other malignant tumors; 13) serious mental disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| duration of remission;progression-free survival; | — |
Countries
China
Contacts
Public ContactWang Huirui
Luoyang Central Hospital
Outcome results
None listed