AIDS related lymphoma
Conditions
Interventions
1:HAART + Anti-CD19 CAR-T treatment
Sponsors
Shanghai PublicHealth Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. male or female aged 18-60 years old; 2. Confirmed as AIDS patients and treated with HAART; 3. Confirmed as refractory or relapse CD19+B lymphoma; 4. Serum test; negative for HBV, HCV and syphilis; 5. Hematology: Absolute neutrophil count greater than or equal to 1000/mm(3);Platelet count greater than or equal to 50,000/mm(3); Hemoglobin greater than 8.0 g/dl; Lymphocyte count less than or equal to 4,000/mm(3); 6. Chemistry: Serum ALT/AST less or equal to 5 times the upper limit of normal. Serum creatinine less than or equal to 1.6 mg/dl. Total bilirubin less than or equal to 1.5 mg/dl; 7. Normal cardiac ejection fraction and no evidence of pericardial effusion as determined by an echocardiogram; 8. Negative pregnancy test for female; 9. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment; 10. To be able to understand and sign the Informed Consent Document with legal force.
Exclusion criteria
Exclusion criteria: 1. With acute disease, active infection, hemolytic anemia, coagulation dysfunction or diseases of the respiratory, circulation or central nervous system; 2. Patients with heart metastases, CNS metastases or cerebrospinal fluid malignant cells; 3. Women with pregnant or breastfeeding; 4. Any form of primary immunodeficiency; 5. Concurrent Systemic steroid therapy; 6. History of severe immediate hypersensitivity reaction to any of the agents used in this study; 7. History of allogeneic stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of CD19+ CAR-T cells in peripheral blood; | — |
Secondary
| Measure | Time frame |
|---|---|
| remission rate of lymphoma;Survival rate of participants;Prognosis factors; | — |
Countries
China
Contacts
Public ContactRenfang Zhang
Shanghai Public Health Clinical Center
Outcome results
None listed