multiple myeloma
Conditions
Interventions
Case series:Combination infusion of CD19 CAR-T cells and mBCMA CAR-T cells
Sponsors
JiangSu Province Hospital of TCM, The First Affilated Hospital of NanJing University of TCM
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Relapsed/refractory multiple myeloma (including plasma cell leukemia) 2. Male or female participants aged 18 to 75 years at time of enrollment. 3. Life expectancy > 12 weeks. 4. ALT/AST < 3 ULN; 5. Total bilirubin <= 2.0mg/dl; 6. Blood T cells was collected intravenously and no other contraindications for aphresis; 7. Informed consent and voluntary subjects.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. 48 hours before; 3. Active hepatitis B or hepatitis C; the immune cell transfusion, the female subject's blood test and urine test were positive for pregnancy. 4. Active hepatitis B, hepatitis C, syphilis or AIDS; 5. Patients who need to use systemic steroid drugs at the same time.Recent or ongoing use of inhaled steroids need not be ruled out; 6. Received any other cell modification therapy in the early stage; 7. Evaluation screening showed that the transfected lymphocytes was less than 5%, or the T cell culture could not be amplified in patients (< 5x); 8. Any uncontrollable positive medical disorder impedes the subject's participation in the study; 9. Unable to give full informed consent due to mental or behavioral impairment; 10. Suspected or proven history of alcohol or drug abuse; 11. Patients participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Countries
China
Contacts
Public ContactXuejun Zhu
Department of Hematology, Affiliated Hospital of Nanjing University of Chinese Medicine (Jiangsu Province Hospital of TCM)
Outcome results
None listed