Plasma cell neoplasms
Conditions
Interventions
CAR19BCMA CAR-T cells group:Using the traditional 3+3 dose escalation method, the initial dose of CAR19BCMA CAR-T cells was 1×10^6/kg, and the dose was planned to increase to 2×10^6/kg and 3×10^6/kg.
Sponsors
The Four Medical Center of PLA General Hospital, China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. With the consent of the person or the legally authorized person and has signed the informed consent form, willing and able to comply with the planned visits, study treatments, laboratory tests and other trial procedures; 2. Patients with relapsed/refractory Plasma cell neoplasms diagnosed by clinical diagnosis: a) Positive expression of BCMA and/or CD19 in clonal plasma cells by flow cytometry or immunohistochemistry; b) Patients with multiple myeloma, plasmacytoma, and plasma cell leukemia who have received at least 3 kinds of drug therapy [proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), anti-CD38 monoclonal antibodies] in the past, and the efficacy has not reached PR or the disease has progressed again after achieving PR or above. c) Patients with systemic light chain amyloidosis who have received at least 2 prior drug therapy [anti-CD38 monoclonal antibody, proteasome inhibitor (PI) or immunomodulatory drug (IMiD)], and the efficacy has not reached PR or the disease has progressed again after achieving PR or above. 3. Age 18 to 75 years old (including boundary value), male and female; 4. Subjects with a physical performance status of 0~2 points in the Eastern Cooperative Oncology Group (ECOG) score; 5. Expected survival of more than 3 months from the date of signing of the informed consent form; 6. HGB >=60g/L (blood transfusion); 7. Liver and kidney function, heart and lung function meet the following requirements: a) creatinine =50%; c) Oxygen saturation >90%; d) Total bilirubin <= 1.5×ULN; ALT and AST <=2.5×ULN; 8. Subject agrees to use contraception from the time of signing the informed consent form until 1 year after receiving CAR-T cell infusion.
Exclusion criteria
Exclusion criteria: If you meet any of the following criteria, you will not be eligible for enrollment: 1. Severe cardiac insufficiency, left ventricular ejection fraction <50%; 2. Have a history of severe pulmonary impairment disease; 3. Combined with other malignant tumors in the advanced stage; 4. Severe infection that cannot be effectively controlled; 5. Combined with severe autoimmune disease or congenital immune deficiency; 6. Active hepatitis (hepatitis B virus deoxyribonucleic acid [HBV-DNA] or hepatitis C virus ribonucleic acid [HCV-RNA] test results above the lower limit of detection); 7. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection; 8. History of severe allergy to biological products (including antibiotics); 9. Allogeneic hematopoietic stem cell transplant patients who still have acute graft-versus-host response (GVHD) one month after discontinuation of immunosuppressants; 10. Presence of other serious physical or psychiatric illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and patients who, in the opinion of the investigator, are not suitable for participation in this study; 11. Female patients (patients of childbearing potential) who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Complete response rate (CRR);Duration of response (DOR);Progression free survival (PFS);Overall survival (OS);Kinetics of CAR-T cells; | — |
Countries
China
Contacts
Public ContactLi Xiaohong
The Four Medical Center of PLA General Hospital, China
Outcome results
None listed