DLBCL
Conditions
Interventions
Sponsors
He'nan Province Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet one of the following conditions: (1) Children who can not take a lot of blood; (2) blood T cells in patients with low levels; (3) There is no single mining conditions, a large number of patients with peripheral blood at risk; (4) T cells unable to amplify, transduction efficiency <10%, or T-cell expansion less than 5-fold in patients who fail to meet the requirements for reinfusion; (5) Cells are repressed in vivo after reinfusion; (6) Patients who can not get autologous CART cell therapy or give up. 2. Histologically validated aggressive B-cell NHL, including the following types defined by WHO 2008: DLBCL; T cells / large cell tissue-rich large B-cell lymphoma; chronic inflammation-associated DLBCL; Epstein-Barr virus (EBV) positive DLBCL elderly; Follicular lymphoma transformed to DLBCL 3. Patient's peripheral blood CD3 positive cell count <0.9x104 / ml; 4. Chemotherapy recurrent disease is defined as any of the following situations: (1) No response to first-line treatment (primary refractory disease); however, subjects who can not tolerate first-line chemotherapy are excluded; (2) The best response to first-line treatment is PD; (3) The best response after first-line therapy for at least 4 cycles is SD (eg, 4 cycles of R-CHOP) and the duration of SD does not exceed 6 months from the start of last dose of treatment; or (4) No response to second-line or later treatment lines; (5) The best response to the most recent treatment is PD; (6) At least 2 cycles The best response after the last treatment is SD, which lasts for no more than 6 months from the last treatment; or (7) autologous stem cell transplantation refractory; (8) Disease progression or recurrence = 12 months after autologous stem cell transplantation (relapse must be confirmed by biopsy in relapsed subjects); (9) If salvage therapy is performed after autologous stem cell transplantation, the subject must not respond to the last-line treatment or relapse after treatment. 5. The subject must have received adequate prior treatment including at least the following: (1) Anti-CD20 Monoclonal Antibody unless Investigators Determine that the Tumor is CD20-negative, as well (2) Chemotherapy regimens containing anthracyclines; For subjects with transformed follicular lymphoma, prior chemotherapy with follicular lymphoma must be accepted and, after conversion to DLBLC, a refractory chemotherapy regimen; 6. There is at least one measurable lesion according to the revised IWG evaluation criteria for malignant lymphoma (Cheson 2007). Unless the progression of the lesion is observed after completion of radiation therapy, lesions previously irradiated are considered measurable lesions; Brain MRI did not show evidence of CNS lymphoma 8. The toxicity of previous treatments must be stable and returned to =1 (except for clinically significant toxicity, such as alopecia); 9. Aged 18 to 65 years; 10. Eastern Cooperative Oncology Group (ECOG) Physical status score was 0 or 1 point; 11. Absolute neutrophil count = 1×10^9/L; 12. Platelet count = 75×10^9/L; 13. Absolute lymphocyte count = 100/uL; 14. Kidney, liver, lung and heart functionally adequate, defined as follows: (1) Creatinine clearance (estimated by Cockcroft Gault method) = 60 mL / min; (2) Serum ALT / AST = 2.5 times upper limit of normal; (3) Total bilirubin = 1.5x upper limit of normal, except for subjects with Gilbert's disease; Ocardial ejection fraction = 50%, echocardiograph
Exclusion criteria
Exclusion criteria: 1. Has a history of malignancy other than melanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) or follicular lymphoma except at least 3 years old; Richter converted history of chronic lymphocytic leukemia; 3. Autologous stem cell transplantation is planned within 6 weeks of the product CD19CART infusion; 4. Allogeneic stem cell transplantation history; 5. Previously received chimeric antigen receptor therapy or other transgenic T cell therapy; 6. There aminoglycoside severe hypersensitivity reaction; 7. There are fungi, bacteria, viruses or other infections that are uncontrollable or require IV antimicrobial treatment management. If there is a response to active therapy, a simple urinary tract infection and no complication of bacterial pharyngitis are allowed after consultation with the medical examiner; 8. Known to be infected with HIV or Hepatitis B (HBsAg positive) or Hepatitis C virus (HCV positive); 9. There are any indwelling catheters or drains (eg, percutaneous nephrostomy tubes, indwelling Foley catheters, bile ducts, or pleural / peritoneal / pericardial catheters). Dedicated central venous catheters, such as implanted intravenous systems or Hickman catheters, are permitted; 10. Subjects detectable with cerebrospinal fluid malignant cells or brain metastases, or with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases; 11. There is a CNS history or disease, such as seizure disease, cerebrovascular ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the CNS; 12. Subjects with atrial or ventricular lymphoid involvement; 13. Myocardial infarction, angioplasty or stenting, unstable angina or other clinically relevant history of heart disease within 12 months prior to enrollment; 14. Because of the impact of tumor mass, urgent treatment is needed, such as bowel obstruction or vascular compression; 15. There are major immunodeficiency; 16. There was a history of deep vein thrombosis or pulmonary embolism within the first 6 months of enrollment; 17. Any disease that may interfere with the safety of the study treatment or assessment of efficacy; 18. Have a history of severe hypersensitivity reactions to any of the drugs in this study; 19. Inject live vaccine =6 weeks prior to starting treatment regimen; 20. Any woman who is fertile or pregnant while undergoing breastfeeding. Women who have undergone sterilization or have been at least 2 years after menopause may be considered unfit for fertility; 21. Male and female subjects unwilling to take birth control 6 months after completion of the licensed CD19CART since the consent form was signed; 22. At the investigator's discretion, it is unlikely that the subject will complete all study visits or procedures required by the program, including follow-up visits or compliance with the study participation requirements; 23. Over the past two years, there was a history of autoimmune diseases (eg, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that result in damage to the terminal organ or require systemic immunosuppression / systemic disease modulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| petCT; | — |
Countries
China
Contacts
Public ContactYongping Song
He'nan Provincial Tumor Hospital
Outcome results
None listed