CD19-positive relapsed, refractory B-cell malignant tumor
Conditions
Interventions
experimental group:CD19 Specificity CART Cell Therapy
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
No minimum to 70 Years
Inclusion criteria
Inclusion criteria: 1. CD19-positive relapsed, refractory B-cell malignant hematological tumor. 2. Under 70 years old. 3. KPS score >= 60, and the expected survival time is >= 3 months. 4. The absolute number of platelets >= 30 * 10^9 / L. 5. Absolute number of lymphocytes >= 0.15 * 10^9 / L. 6. Serum ALT <= 100U / L; AST <= 100U / L. 7. Total bilirubin <= 30µmol. 8. Creatinine <= 200µmol / L. 9. Women of childbearing age who had a negative urine pregnancy test before the start of administration and agreed to take effective contraception during the test until the last follow-up. 10. Participate voluntarily in the group, have good compliance, be able to cooperate with the experimental observation, and sign the written informed consent.
Exclusion criteria
Exclusion criteria: Patients who do not meet any of the following criteria cannot be selected for this study: 1. Clinical diagnosis (symptoms, signs, imaging, cerebrospinal fluid) of central nervous system leukemia. 2. Patients with hyperleukemia (leukocyte count >= 50 * 10^9 / L) or when the subjects are enrolled according to the investigator's judgment that the disease progresses rapidly and cannot ensure a complete treatment cycle. 3. Patients with fungal, bacterial, viral or other uncontrollable infections or who require four levels of isolation to manage infections. 4. Patients with positive HIV, HBV and HCV tests. 5. Patients with central nervous system diseases including stroke, epilepsy, dementia, or autoimmune central nervous system diseases. 6. Within 12 months before enrollment, accompanied by myocardial infection, cardiac angiography or stent, active angina or other obvious clinical symptoms, or accompanied by cardiopathic asthma or cardiovascular lymphocyte infiltration. 7. Those who are receiving anticoagulant therapy or have severe coagulation dysfunction (APTT> 70). 8. According to the investigator's judgment, the drug treatment the patient is receiving will affect the safety and effectiveness of this project. 9. Patients with allergies or a history of allergies to the biological agents used in this project. 10. Pregnant or breastfeeding women. 11. Those who systematically use systemic and systemic steroid drugs within 2 weeks before participating in the treatment (except those who have recently or are currently using inhaled steroids). 12. Suffering from other uncontrolled diseases, which the researchers think is not suitable for joining. 13. The investigator believes any situation that may increase the patient's risk or interfere with the test results. 14. Patients participating in other clinical studies at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Remission;Partial Response;Stable Disease;Progressive Disease; | — |
Countries
China
Contacts
Public ContactZhai Zhimin
Hematology Department, Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed