AIDS-related B-cell lymphoma&HIV
Conditions
Interventions
1:CD20-targeting iNKT cells
2:anti-CD19/CD22 CAR-T cells
3:anti-CD19/CD22 CAR-T cells combined with HIV-specific CAR-T cells
HIV-specific CAR-T cell:HIV-specific CAR-T cells
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Male and female 2. Aged 18-60 years; 3. AIDS patients receiving HAART treatment; 4. HIV infected only or HIV infected together with CD19+/CD20+/CD22+ B cell lymphoma confirmed by histopathology or flow cytometry; 5. The diagnosis of refractory or relapsed lymphoma should meet any of the following criteria: (1) the tumor was shrunk by less than 50% or the disease progression through the first-line and second-line chemotherapy for four cycles; (2) complete response (CR) was achieved by the first-line and second-line chemotherapy, but relapsed within half a year; (3) two or more relapses after CR; 6. Serological test: the serum markers of HBV, HCV, syphilis and other infections are all negative, or HBV/HCV/syphilis/ tuberculosis/other infection is being treated or cured; 7. Routine blood test: (1) Absolute neutrophil values =1.0×10^9/L for HIV-infected only participants or the absolute value of neutrophils in the patients without bone marrow involvement >= 1.5x10^9/L, and the absolute value of neutrophils in the patients with bone marrow involvement >= 1.0x10^9/L for participants with HIV-combined B-lymphoma; (2) the hemoglobin in the patients with bone marrow involvement >= 90g/L (in the case of no red blood cell transfusion within 14 days), and the hemoglobin in the patients with bone marrow involvement >= 75 g/L; (3) the platelet in the patients without bone marrow involvement > 75 x 10^9/L, and the patients with bone marrow involvement Platelets > 50 x 10^9/L; 8. Blood biochemical test: serum total bilirubin = 50ml/min (according to Cockcroft Gault formula); 9. Echocardiography: hemodynamic stability and left ventricular ejection fraction (LVEF) >=45%; 10. Physical fitness score: if participants with HIV-combined B-lymphoma, ECOG physical fitness score is 0 or 1; 11. Estimated survival time: at least 12 weeks; 12. Venous access: adequate venous access (single or venous blood collection); 13. Lesion evaluation: if participants with HIV-combined B-lymphoma, at least one measurable lesion (IWG response standard cheson 2014) is used as the evaluation basis: for intranodal lesions, the long diameter >=1.5 cm and the short diameter >=1.0 cm; for extranodal lesions, the long diameter >= 1.0 cm; 14. Use of biological products: no transfusion of cell growth factor (except recombinant erythropoietin), platelet and granulocyte was received within 7 days before cell transfusion; 15. Female subjects: female subjects of childbearing age must carry out serum pregnancy test during screening and before infusion of this test product, and the result is negative. They are willing to use a very effective and reliable method of contraception within one year after receiving treatment. Methods to be used include: bilateral tubal ligation / bilateral salpingectomy or bilateral tubal occlusion; or approved contraceptive method of oral, injection or hormone implantation; or barrier contraceptive method: condom or closed cap (diaphragm or cervix / dome cap) containing spermicidal foam / gel / film / cream / suppository; 16. Male subjects: if male subjects have active sexual life with women with reproductive potentia
Exclusion criteria
Exclusion criteria: 1. History of severe allergy, or history of allergy or intolerance to topiramab, or history of allergy or intolerance to components in car-t cell preparations; 2. Received chemotherapy, targeted therapy, radiotherapy and other anti-tumor treatment within 14 days before the operation; 3. We have received allogeneic hematopoietic stem cell transplantation in the past; we have received autologous stem cell transplantation within 12 weeks before single collection; 4. In the past 5 years or now, there are other malignant tumors, except for breast / cervical carcinoma in situ, basal cell carcinoma and superficial bladder tumor (TA, tis, T1); 5. Any uncontrollable active infection, including but not limited to active tuberculosis patients (including T-SPOT positive); 6. Patients who received systemic steroids (prednisone > 20mg / day or other hormones of the same dose) or other immunosuppressive agents within 7 days before the treatment, except those who had recently or currently used inhaled steroids; 7. It is known to have active autoimmune diseases, including but not limited to psoriasis, rheumatoid arthritis and other diseases requiring long-term immunosuppressive treatment; 8. Inoculate live attenuated vaccine within 6 weeks before single collection; 9. In patients with refractory hyponatremia and / or hypokalemia, blood sodium 160 mmHg, diastolic blood pressure > 100 mghg), pulmonary embolism or other diseases think that participating in this clinical trial may damage the health of patients; 13. LVEF 95% (finger pulse oxygen); 15. According to the judgment of the investigator, any serious or uncontrollable systemic disease, systemic complications, other serious concurrent diseases (such as Haemophilus syndrome, etc.), tumor special conditions may make the patient unfit to enter the study or affect the compliance of the program, or significantly interfere with the correct evaluation of the safety, toxicity and effectiveness of the study drug; 16. The investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol; 17. Major surgery was performed within 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse effects incidence; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate, ORR;complete response,CR;Disease Control Rate, DCR;Duration of Response, DoR;duration of disease control,DDC;progression-free survival, PFS;Overall Survival,OS; | — |
Countries
China
Contacts
Public ContactRenfang Zhang
Shanghai Public Health Clinical Cente
Outcome results
None listed