Leukemia and Lymphoma
Conditions
Interventions
experimental group :AT19
Sponsors
The General Hospital of Western Theater Command
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. In patients with B-lymphoblastic leukemia, CD19 expression in leukemia cells was positive. 2. Recurrent/refractory B-lymphocytic leukemia is defined as one or more of the following: 1) patients who have not achieved complete remission for two courses of treatment with standard induction-remission chemotherapy regimen; 2) those who relapse within six months after the first remission; 3) those who relapse six months after the first remission, but fail to be treated again with the original induction-remission regimen; Recurrent cases. 5) Recurrence after failed bone marrow transplantation OR 3. Histopathologically confirmed CD19-positive B-cell lymphomas include diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, lymphoplasmic lymphoma and chronic lymphoblastic leukemia. 4. Refractory B-cell lymphoma is defined as one or more of the following: 1) No response to first-line treatment (primary refractory diseases); excluded first-line treatment of chemotherapy intolerance subjects: The best effect of first-line treatment is disease progression (PD); The optimal outcome of first-line treatment for at least 4 cycles (e.g. 4 cycles of R-CHOP) was disease stability (SD), and the duration of SD after the last dose was not more than 6 months. 2) No remission was found for second-line or later-line treatment: The best effect of end-line therapy is PD. The best outcome was SD after at least 2 cycles of end-line treatment, and the duration of SD was not more than 6 months after the last dose of treatment. 3) Difficult treatment after autologous hematopoietic stem cell transplantation (ASCT): Disease progression or recurrence of ASCT less than 12 months (must be confirmed by biopsy); If salvage treatment is performed after ASCT, the subject must have no remission of the end-line treatment or relapse after treatment. And all the following conditions are satisfied: 5. No central nervous system leukemia/lymphoma. 6. Previous systemic therapy had at least 2 weeks or 5 half-lives (whichever was shorter) from the start of preconditioning chemotherapy, except for immuno-checkpoint inhibitors/agonists; systemic immuno-checkpoint inhibitors/agonists had at least 3 half-lives (e.g., ipilimumab, etc.) from preconditioning chemotherapy. 7. The toxicity induced by previous anti-lymphoma therapy must be stabilized and restored to grade 3 months). 12. Normal or abnormal functions of kidney, liver, lung and heart but without clinical significance. 13. Creatinine clearance rate (estimated by Cockcroft Gault formula) > 60 mL/min; 14. Serum ALT/AST 50%). Echocardiography confirmed no pericardial effusion and ECG had no abnormal discovery of clinical significance; 17. Pleural effusion without clinical significance; 18. Serum pregnancy test results for fertile women should be negative (women who have undergone surgical sterilization or at least two years after menopause do not consider themselves fertile).
Exclusion criteria
Exclusion criteria: 1. Central system leukemia/lymphoma. 2. Subjects had other malignant tumors, non-melanoma skin tumors, and carcinoma in situ (e.g. cervix, bladder, breast), unless they survived disease-free for at least three years. 3. The presence or suspicion of fungi, bacteria, viruses or other infections beyond control or requiring intravenous administration. 4. Known human immunodeficiency virus (HIV) infection. 5. Hepatitis B (HBsAg positive) or hepatitis C (HCV antibody positive). 6. Existing or previous CNS diseases, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar diseases or any CNS-related autoimmune diseases. 7. Severe cardiac diseases, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction in the first six months of screening, or any grade 3 (moderate) or 4 (severe) heart disease (according to NYHA), with lymphoma infiltration in the atrium or ventricle Subjects. 8. Patients with myocardial infarction, angioplasty or stenting, unstable angina or other clinically significant heart disease history within 12 months before admission. 9. Emergency treatment (e.g. tumor mass compression) is expected or likely to occur within 6 weeks due to rapid progression of tumors. 10. Primary immunodeficiency. 11. History of symptomatic deep venous thrombosis or pulmonary embolism within 6 months before admission. 12. Any medical condition that may affect the assessment of safety or efficacy. 13. Any drug used in this study had a severe rapid-onset hypersensitivity. 14. Live vaccination less than 6 weeks before the start of pretreatment. 15. Female subjects during pregnancy or lactation. 16. Men or women who disagreed with effective contraception from the time of signing informed consent to six months after AT19 treatment. 17. The participants judged by the researchers were unable to complete all the visits or operations required by the research program (including follow-up visits), or were not sufficiently compliant to participate in the study. 18. End organ damage due to autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or the need for systemic use of immunosuppressive or other systemic disease control drugs in the past two years. 19. The number of autologous T lymphocytes is less than 4 *109 mononuclear cells; or it is impossible to find a suitable donor for HLA matching.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-Limiting Toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Therapeutic effect; | — |
Countries
China
Contacts
Public ContactYi Su
The General Hospital of Western Theater Command
Outcome results
None listed