Relapsed/refractory Malignant plasmacyte disease
Conditions
Interventions
ICG186-1 low dose:BCMA-CAR-T cells (ICG186)2.5 x10*5/kg
ICG186 low- intermediate dose:BCMA-CAR-T cells (ICG186)5 x10*5/kg
ICG186 intermediate-high dose:BCMA-CAR-T cell (ICG186)10 x10*5/kg
ICG186 high dose:BCMA-CAR-T cells (ICG186)20 x10*5/kg
ICG180 low dose:BCMA/CS1-CAR-T cells (ICG180)2.5 x10*5/kg
ICG180 low-intermediate dose:BCMA/CS1-CAR-T cells (ICG180)5 x10*5/kg
ICG180 intermediate-high dose :BCMA/CS1-CAR-T cells (ICG180)10x10*5/kg
ICG180 high dose:BCMA/CS1-CAR-T cells (ICG180)20x10*5/kg
ICG181 low dose:BCMA/CD19-CAR-T cells (ICG181)2.5x10*5/kg
ICG181 low-intermediate dose:BCMA/CD19-CAR-T cells (ICG181)5x10*5/kg
ICG181 intermediate-high dose:BCMA/CD19-CAR-T cells (ICG181)10x10*5/kg
ICG181 high dose :BCMA/CD19-CAR-T cells (ICG181)10x10*5/kg
Sponsors
Department of Hematology, The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed as malignant plasma disease (MPD) (including solitary / multiple myeloma, extramedullary plasma cell disease, plasma cell leukemia, Fahrenheit's macroglobulinemia, primary amyloidosis, and severe chain disease). 2. In the relapsed / refractory cases, the response to conventional chemotherapy is poor, and the proportion of malignant plasma cells in bone marrow or peripheral blood is more than 5%: (1) The patients who did not reach complete remission in 4 courses were treated with the standard scheme including new drugs such as bortezomib and lenalidomide; (2) Relapse within 6 months after the first remission; (3) The patients recurred 6 months after the first remission, but were treated again with the original or new regimen; (4) Multiple recurrences; (5) Relapse after autotransplantation or allogeneic hematopoietic stem cell transplantation (HSCT); (6) Routine chemotherapy for 4 courses did not achieve complete remission or relapse after remission, but could not receive new drug treatment due to economic reasons. 3. Patients who relapsed after allo HSCT were at least three months away from the transplantation time, and did not use drugs to prevent or treat GVHD when included in this study, and did not show active GVHD. 4. According to age, comorbidity, donor, funding and other comprehensive evaluation conditions, subjects who are willing to participate in clinical trials. 5. Age: 18-70 years old; 6. Patients with expected survival time >= 3 months; 7. In the patients with normal cardiopulmonary function, the ejection fraction is more than 50% as indicated by color Doppler echocardiography, and the oxygen saturation of fingers is more than 94% in the resting state without oxygen inhalation; 8. Patients without obvious active infection; 9. Patients with physical strength score of 0-2 (ECoG standard); 10. There is no contraindication for patients who have suitable vein for blood cell single collection or whole blood collection; 11. Because the effect of icg186 / icg180 / icg181 car T cell therapy on the fetus is unknown, it is necessary for women of childbearing age to have negative serum or urine pregnancy test 48 hours before car T cell transfusion, and agree to take effective contraceptive measures during the test until the last follow-up; 12. Voluntary participation and informed consent signed by the patient or his legal / entrusted agent.
Exclusion criteria
Exclusion criteria: 1. Patients who have used car T cells or failed other immunotherapy; 2. Patients who are allergic to any research drug involved in the program; 3. The AST / ALT was more than 3 times of the upper limit of normal value in the patients with obvious abnormality of liver and kidney function, and the bilirubin was more than 34.2µ mol / L (2.0 mg / dl), serum creatinine > 221.0 µ mol / L (2.5mg / dl); 4. Patients with serious heart disease, such as uncontrolled or symptomatic arrhythmia, congestive heart failure, or myocardial infarction within 6 months before exhaustion or screening, or any cardiac function level 3 (moderate) or 4 (severe) heart disease (according to NYHA); 5. Patients with serious lung disease and respiratory insufficiency; 6. Patients with clinically significant history of central system diseases, such as epilepsy, paralysis, cerebrovascular diseases Severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, etc.; 7. Patients with active and uncontrollable infection; 8. HIV positive patients; 9. Patients with active hepatitis B or C; 10. Patients who currently use steroids in general (except inhaled steroids); 11. Patients with uncontrolled malignant tumors of other organs or other malignant tumors are stable Patients who have been given chemotherapy / surgery / targeted therapy / biotherapy for less than 5 years; 12. Pregnant or lactating women. 13. Patients with drug addiction or mental illness. 14. Subjects who are unable to understand or comply with the research plan. 15. Participants in other clinical studies at the same time. 16. If there is any other disease history or current disease with clinical significance, it may bring risks to the safety of the subjects, or interfere with the completion of the research procedure and the evaluation of safety and efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission rate at the first month; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative relapse rate;2 years disease free survival;2years overall survival; | — |
Countries
China
Contacts
Public ContactBing Xu
Department of Hematology, The First Affiliated Hospital of Xiamen University
Outcome results
None listed