relapse/refractory hematological malignancy
Conditions
Interventions
experimental group:CAR- T cell infusion:
Before reinfusion of CAR-T cells, at least three people (doctors, nurses and cell preparation technicians) shall strictly check the patients name, gender, age,
Sponsors
Hematology Department, the Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria 1 (for patients with relapsed and refractory lymphoma related to non EB virus infection) (1) Patients with hematological malignancies failed to respond to traditional treatment or relapsed and were difficult to treat. Flow cytometry or pathological immunohistochemistry were used to confirm that tumor cells expressed specific molecular targets such as CD19, CD20, CD22, BCMA, etc. (2) The age ranged from 3 to 75 years old, both male and female. (3) Physical condition is good: ECoG score is 0-2 points. (4) It is generally required that the peripheral blood cell count is basically normal (i.e., white blood cell >= 4.0 × 10^9/L, hemoglobin >100g/L, platelet count >= 50 × 10^9/L). After fully informing the patient of the relevant risks and obtaining understanding and consent, the peripheral blood cell index can be relaxed to white blood cell >= 2.0 × 10^9/L, hemoglobin > 60g/l, platelet count >= 30 × 10^9/L. however, the peripheral blood T lymphocyte count must be >= 0.2 × 10^9/L at the time of blood collection. (5) There was no obvious abnormality in heart, liver and kidney functions (i.e. ECG was basically normal; renal function: Cr = 10 ^ 3 copies/ml); (3) The current medical history or screening showed that the tumor tissues were gp350 positive or EBV positive (>=10% of tumor cells expressed gp350 or eber-ish positive); (4) There was no EBV infection in peripheral blood CD3+cells; (5) According to Lugano criteria, lymphoma lesions can be evaluated; (6) Age 18 to 70 years old (including the cut-off value); (7) ECoG physical status score was 0-2 points; (8) The estimated survival time is more than 3 months; (9) Women of childbearing age who had negative blood pregnancy test before the trial and agreed to take effective contraceptive measures during the trial until the last follow-up; Male subjects with fertile partners agreed to take effective contraceptive measures during the trial until the last follow-up; (10) Without blood transfusion and/or other growth factor treatment in the past 4 weeks: 1) If the subjects had no bone marrow invasion, neutrophil count >= 1.0 × 10 ^ 9/L, hemoglobin >= 80g/L, platelet count >= 50 × 10 ^ 9/L, lymphocyte count >= 0.2 × 10 ^ 9/L; 2) If the subject has lymphoma invasion in the bone marrow, the investigator shall determine whether the blood routine examination results meet the requirements for enrollment; (11) Liver, kidney, heart and lung functions meet the following requirements: 1) Creatinine clearance rate >= 60ml/min; 2) ALT and AST = 50%, no pericardial effusion, no clinically significant abnormality in ECG; 4) No or only a small amount of pleural effusion and peritoneal effus
Exclusion criteria
Exclusion criteria: 1. Malignant cells do not express intervene molecular targets 2. Organ failure, such as heart failure: Class III and IV; liver: to Child-Pugh grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: a disorder of consciousness; 3. Existing serious acute infection, uncontrollable, or have fester wound and chronic infection; 4. Patients with significant graft versus host disease (GVHD) after organ transplant, or allogeneic hematopoietic stem cell transplantation; 5. Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution. 6. Coagulation abnormalities and severe thrombosis; 7. Pregnancy and lactation women; 8. Any other chronic disease patients who have been treated with immune agents or hormone therapy; 9. Patients who are participating or have participated in other clinical trials in the past 30 days; 10. The Investigator believes the patients should not participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate;Adverse effects rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival ;Event Free Survival, EFS ;Recurrence Free Survival, RFS; | — |
Countries
China
Contacts
Public ContactZhimin Zhai
The Second Hospital of Anhui Medical University
Outcome results
None listed