B cell leukemia/ lymphoma
Conditions
Interventions
experimental group:Universal CAR-T cells
Sponsors
Medical Center of Hematology, Xinqiao Hospital, Army Medical University
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or Femal aged from 14 to 70 years; 2. Refractory/relapsed B cell leukemia/lymphoma with the anyone of following conditions: (1) Relapse: Two or over two times relapse or relapse after allogeneic hematopoietic stem cell transplantation with >=5% blast cells or MRD+ ; (2) Refractory: No CR after chemotherapy with two cycles; (3) The ph+ B-ALL with the anyone of following conditions: 1) Cant tolerant TKI; 2) Progression of the first and the second KTI; 3) Unfitable for allogeneic hematopoietic stem cell transplantation; 3. The CD19 was positive in the leukemia/lymphoma cells; 4. ECOG performance status of = 60mL/min; 3) Total bilirubin = 50% without hydropericardium and abnormal electrocardiogram; 5) Ward with natural air and oxygen saturation>92%. 7. Venous access is available and no contraindication for collection of white blood cells. 8. HCG is negative during screening and before chemotherapy and contraception was agreement during treatment; 9. Understand and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Only extramedullary relapse for patients with B-cell acute lymphoblastic leukemia; 2. With other cancer except the patients with non-melanomaskin cancercervical carcinoma in situbladder cancer and breast cancer and so on for over 5-year disease-free survival; 3. Serious psychiosis; 4. Genetic disease, such as Fanconi anemia, Shwachman-Diamond syndrome, Kostmann's syndrome or other bone marrow failure syndrome; 5. With aGVHD or extensive cGVHD with grade II-IV; 6. Heart failure with grade III-IV, myocardial infarction, cardioangioplasty or cardiac stenting, unstableangina or other heart disease with clinical complication before one year of study; 7. With catheters or drainage tube except central venous catheter; 8. Leukemia in the CFS or brain metastases of cancer or CNS lymphoma; 9. History of central nervous system diseases, such as Epileptic seizures, Cerebrovascular ischemia or bleeding, dementia, cerebellar diseases, autoimmune disease of CNS disease; 10. HIV is positive; The HBsAg or HbcAb and HBV-DNA is positive; HCV-RNA is positive; other serious active virus and bacterial infection or uncontrolled invasive fungal infection. 11. Allergy or serious history of allergy; 12. Autoimmune disease caused injury of terminal organ or need of systemic immunosuppression in the past two years, such as crohn's disease, rheumatoid arthritis, systemic lupus erythematosus; 13. With interstitial lung disease such as lung fibrosis or pneumonia; 14. Low compliance or cant comply with research proposal and follow-up; 15. Contraindication for cyclophosphamide or fludarabine; 16. Patients need treatment with systemic corticosteroids(>= 5mg/d)or immunosuppressive drugs except the treatment of adverse events; 17. Received donor lymphocyte infusion or join the other clinical trial within four weeks; 18. Received gene treatment or CAR-T cells in the past or received any targeted drugs or other trial drugs 19. Patients can not be enrolled which will be judged by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event of 12 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;disease-free survival;Overall survival;CAR copies;Level of cytokines;Lymphocyte subset;Level of anti-CART antibody; | — |
Countries
China
Contacts
Public ContactZhang Xi
Medical Center of Hematology, Xinqiao Hospital, Army Medical University
Outcome results
None listed