plasma cell malignancies
Conditions
Interventions
Case series:Anti-BCMA CAR-T
Sponsors
Tongji Hospital of Tongji Medical College, Huazhong University of Science
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. All subjects or legal representatives must personally sign in writing the informed consent form approved by the Ethics Committee before starting any screening procedures; 2. Aged 18 to 70 years old male and female, meet the multiple myeloma efficacy evaluation criteria (IMWG) diagnosed as relapsed or refractory multiple myeloma, of which recurrence or refractory is defined as: after at least 3 Multiple myeloma that is ineffective or relapse after line therapy (including proteasome inhibitors and immunomodulator-based chemotherapy regimens), with continuous induction of induction chemotherapy, stem cell transplantation, and maintenance therapy, if no disease progression occurs during treatment, For a treatment plan; 3. Patients with previous BCMA CAR-T cells (without BCMA antibody source) were infused once, and CRS = 3 and CRES = 3 during treatment; 4. Patients must have measurable lesions when enrolled: (1) The proportion of monoclonal plasma cells in the bone marrow is >=5% (including bone marrow cytology smear, bone marrow pathology and flow cytometry, the highest value); (2) Serum monoclonal protein (M-protein) levels >=5 g/L; (3) Light chain multi-energy myeloma with no detectable lesions in serum or urine: serum immunoglobulin free light chain >=100 mg/L and abnormal serum immunoglobulin k/gama free light chain ratio; (4) Extramedullary lesions; (5) The disease progresses to the stage of plasma cell leukemia; 5. The expression of BCMA on the surface of clonal plasma cell membrane was positive by flow cytometry or immunohistochemistry; 6. The ECOG score is 0 ~ 2 points (see Appendix 4 for ECOG scores); 7. Expected survival time >=12 weeks; 8. Subjects must have appropriate organ function and meet all of the following laboratory findings before enrollment: (1) Blood routine: neutrophils >=1.0x10^9/L; hemoglobin >=60 g/L; platelets >=40x10^9/L; (2) Liver function: ALT and AST = 40 ml/min. (4) Coagulation function: fibrinogen >=1.0g/L; activated partial thromboplastin time 91%; (6) Hemodynamically stable and left ventricular ejection fraction (LVEF) >=50% as determined by echocardiography; 9. There must be non-mobilized collection of cells for CAR-T cell production or qualified CAR-T cell preparations; 10. Women of childbearing age and male subjects with fertility must take effective contraceptive measures throughout the study and within 12 months of discontinuation of treatment.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded: 1. History of previous treatment: (1) Patients who have undergone autologous hematopoietic stem cell transplantation or who have previously received allogeneic hematopoietic stem cell transplantation within 12 weeks prior to return; (2) Received other clinical trials within 2 weeks prior to returning; (3) Received chemotherapy (including targeted therapies, monoclonal antibodies, proteasome inhibitors or immunomodulators, etc.) or used invasive experimental medical devices within 14 days prior to returning; (4) Long-term use of glucocorticoid therapy before single blood sampling; 2. History of the disease and history of surgery (1) Patients with a central nervous system invasion of plasma cell tumors; (2) Those with a history of hypertension who have been treated with medication for > 140/90 mmHg; (3) There is a serious cardiovascular disease that the investigator judges is not suitable for participation. Such as severe arrhythmia, congestive heart failure, etc.; (4) Those with a history of solid organ transplants; (5) Not suitable for clinical trials at the discretion of the investigator; 3. In the screening period or within 3 days before the start of dosing, there is fever or the investigator judges that there is an uncontrollable, active infectious disease; 4. Active hepatitis B (defined as hepatitis B virus DNA detection > 100 IU / mL) or hepatitis C (HCV RNA positive) patients; HIV-positive or treponema-positive patients; 5. Women during pregnancy or lactation or women and men with birth plans.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactZhou Jianfeng
Department of Hematology, Tongji Hospital of Tongji Medical College, Huazhong University of Science
Outcome results
None listed