multiple myeloma
Conditions
Interventions
Sponsors
Huizhou Municipal Central Hospital
Eligibility
Sex/Gender
All
Age
5 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Chinese subjects aged =5 years; 2) Patients diagnosed with multiple myeloma according to IMWG diagnostic criteria. 3) The presence of measurable lesions during screening was determined according to any of the following criteria: serum m-protein level =1.0 g/dL or urinary M-protein level =200 mg/24 hours; Light chain multiple myeloma with no measurable lesions in serum or urine: =10 mg/dL free light chain immunoglobulin and abnormal free light chain immunoglobulin ?/? ratio. Study specific definition: In multiple myeloma, where only FLC was measurable, serum or urinary M protein levels did not meet measurable criteria 4) ECOG physical fitness level = 2 (see Appendix 2). 5) The clinical laboratory values during the screening period met the following criteria: hemoglobin =8.0 g/dL (no red blood cell infusion [RBC] within 7 days prior to laboratory examination; Recombinant human erythropoietin is permitted, and for subjects who meet the inclusion criteria at screening, red blood cell infusion is permitted after the first hematologic examination at screening to maintain hemoglobin levels =8.0 g/dL); Platelet =75×109/L (must not have received transfusion support within 7 days prior to laboratory examination); Lymphocyte count: =0.3×109/L; Neutrophil absolute count (ANC) =1.0×109/L (growth factor support is allowed, but must not have been supported within 7 days prior to laboratory examination); Serum ALT/AST=3.0× normal upper limit (ULN); Creatinine clearance rate =50 mL/min, serum creatinine =2.5 mg/dL, calculated according to modified dietary formula for kidney disease or 24 hours urine collection results; Total bilirubin =2.0×ULN; Subjects with congenital bilirubinemia, such as Gilbert syndrome, in which direct bilirubin =1.5×ULN is required, are excluded; Adjusted serum calcium =12.5 mg/dL (=3.1 mmol/L) or free calcium =6.5 mg/dL (=1.6 mmol/L); Cardiac ejection fraction =45%, echocardiography examination confirmed no pericardial effusion, no clinically significant ecg findings; There was no clinically significant pleural effusion; Baseline oxygen saturation >92% indoors. 6) Fertile women must be negative for a highly sensitive serum pregnancy test (ß human chorionic gonadotropin [ß -HCG]) at screening time and before initial treatment with cyclophosphamide and fludarabine. 7) Fertile women must comply with the following requirements: Subjects must agree to use a highly effective contraceptive method and agree to continue using a highly effective contraceptive method for at least 100 days from signing the informed consent (ICF) to receiving the infusion. 8) The venous access required for collection can be established, without contraindications for white blood cell collection. 9) Subjects must sign an ICF indicating that they understand the purpose and procedures of the study and are willing to participate in the study. Informed consent must be obtained before initiating any study related tests or procedures that are not part of the standard treatment of the subject's disease. 10) Willing and able to follow the taboos and restrictions stipulated in the program.
Exclusion criteria
Exclusion criteria: 1) Previous CAR-T therapy targeting any target. 2) Have received any treatment targeting BCMA. 3) Have been diagnosed with or treated for invasive malignancies other than multiple myeloma, except for those who have received radical therapy and have no known active disease for =3 years prior to enrollment; Or adequately treated non-melanoma skin cancer with no evidence of disease. Prior antitumor therapy (prior to monopheresis) : targeted therapy, epigenetic therapy, or experimental drug therapy, or use of an invasive experimental medical device, within 14 days or for at least 5 half-lives, whichever is less. Multiple myeloma was treated with monoclonal antibodies within 21 days. Cytotoxicity therapy was performed within 14 days. They were treated with a proteasome inhibitor within 14 days. Immunomodulators were administered within 7 days. Radiation was given within 14 days. But if the radiation field covered no more than 5% of bone marrow reserve, subjects were eligible for the study regardless of the end date of radiation therapy. 5) With the exception of alopecia or peripheral neuropathy, toxicity from previous antitumor therapy must improve to baseline or = grade 1 6) Present with the following heart conditions: NYHA Stage III or IV congestive heart failure; Had myocardial infarction or received coronary artery bypass graft (CABG) =6 months before enrollment; A history of clinically significant ventricular arrhythmias, or unexplained syncope, non-vasovagal or not due to dehydration; A history of severe non-ischemic cardiomyopathy; Assessment of impaired cardiac function by echocardiography or multiplex circuit detection (MUGA) scan (=8 weeks before monotherapy) (LVEF 2.0×109/L according to the standard classification), Fahrenheit macroglobulinemia, POEMS syndrome (polyneuropathy, organ enlargement, endocrine lesions, monoclonal proteinopathy, and skin changes) or primary AL amyloidosis at screening. 10) Human immunodeficiency virus (HIV) seropositivity. 11) Received live attenuated vaccine within 4 weeks prior to monopectic blood collection. 12) Infected with active hepatitis B or C virus. 13) Serious underlying medical conditions, such as evidence of severe active viral or bacterial infection or uncontrolled systemic fungal infection; Active autoimmune disease or a history of autoimmune disease within 3 years; There is clear clinical evidence of dementia or altered mental state. 14) Any issues that are not conducive to the subject's acceptance or tolerance of planned treatment at the study center, understanding of informed consent, or any condition that the investigator considers is not in the subject's best interest (e.g. harmful to health) to participate in the study, or any condition that may prevent, limit, or confuse the evaluation prescribed in the study protocol. 15) Female subjects who are pregnant, breast-feeding, or planning to become pregnant during the study period or within 100 days after the study treatment. 16) Male subjects who planned to have children during the study period or within 100 days of study treatme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Countries
China
Contacts
Public ContactGuowei Li
Outcome results
None listed