B-cell malignancies
Conditions
Interventions
All:CD19-targeted chimeric antigen receptor T-cell
Sponsors
Istitute of Hematology, Union Hospital,Tongji Medical College,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient is pathologically and histologically confirmed as CD19 + B cell tumors, and has no effective treatment options currently, such as chemotherapy or autologous hematopoietic stem cell transplantation (auto-HSCT) / relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT) treatment; or patients voluntarily choose CD19 CAR-T cells as a first treatment; 2. B cell hematological malignancies include the following three categories: 1) B-cell acute lymphocytic leukemia (B-ALL); 2) Indolent B-cell lymphoma (CLL, FL, MZL, LPL); 3) Aggressive B-cell lymphoma (DLBCL, BL, MCL); 3. 6 months; 5. Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit; 6. Voluntarily participate in this experiment and sign informed consent by themself, or legally authorized representative.
Exclusion criteria
Exclusion criteria: 1. With a history of epilepsy or other central nervous system diseases; 2. Having graft-versus-host reaction and requiring the use of immunosuppressants; 3. The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in grade 3 (moderate) or 4 ( severe) (according to the New York Heart Association Functional Classification System); 4. Pregnant or lactating women (safety of this therapy for the unborn child is unknown); 5. Not curable active infection; 6. Patients with active hepatitis B or hepatitis C virus infection; 7. Combined use of systemic steroids within two weeks (except for the use of inhaled steroid recently or currently); 8. Using product of gene therapy before; 9. Creatinine> 2.5 mg / dl (221.0 umol/L); ALT / AST> 3 X the normal amount; Bilirubin> 2.0 mg / dl (34.2 umol/L); 10. Patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial; 11. Patients with HIV-infection; 12. Any situation the researchers believe that may increase the risk of patients or interfere with test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| white blood cell;platlet;hemoglobin;interferon-?;tumor necrosis factor-a;interleukin-6;interleukin-10;interleukin-2;interleukin-2 receptor;C reactive protein;chimeric antigen receptor T-cell; | — |
Countries
China
Contacts
Public ContactYu Hu
Istitute of Hematology, Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Outcome results
None listed