Clinical Research Directory

Inclusion Criteria: * 18 years old≤ subjects \< 75 years old, all genders; * Patients volunteered to participate in the study, and they or their legal guardians signed informed consent form (ICF); * According to the diagnostic criteria of the "The Guidelines for Diagnosis and Treatment of Multiple Myeloma in China (2022)", patients with multiple myeloma are clearly diagnosed; * Patients without indications for hematopoietic stem cell transplantation； * Meet the definition criteria of relapsed or refractory multiple myeloma. Patients failed at least 3-line of anti-multiple myeloma therapy have at least 2 complete treatment cycles per line, unless the best response to the therapy was recorded as disease progression; Must have a record of disease progression during or within 12 months after the last treatment; * Applicable only in the dose expansion phase: the surface BCMA positive percentage of plasma cells of bone marrow samples by flow cytometry is ≥ 50 %; * Patient has one or more measurable multiple myeloma lesions； * Patients must have appropriate organ function; * Patients had no contraindications to peripheral blood mononuclear cell collection; * ECOG score 0-2; * Expected survival ≥ 12 weeks; * Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to cell therapy and not be lactating. Exclusion Criteria: * Have a history of allergies to cyclophosphamide, fludarabine, or any component of the cell product; * Severe cardiovascular and cerebrovascular diseases; * Severe comorbidities or diseases that the researchers believe will put the patients at inappropriate risk or interfere with the study; * Have a history of allogeneic hematopoietic stem cell transplantation, or received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks prior to signing the ICF; * Central nervous system (CNS) involvement or symptoms of CNS involvement or CNS metastases; * Stroke or seizure occurred within 6 months prior to signing the ICF; * Previous plasma cell leukemia; * Multiple myeloma with extramedullary lesions; * Previous or screening examination showing amyloidosis; * Malignant tumor cells with T cell origin revealed by previous pathological examination; * Having autoimmune disease, immunodeficiency or other disease that requires immunosuppressant therapy; * Within 5 years prior to signing the ICF, patients with malignancies other than multiple myeloma; * Uncontrolled active infection; * Systemic disease judged by the investigator to be unstable; * More than 5 mg/day of prednisone (or equivalent amounts of other corticosteroids) within 1 week prior to apheresis; * Have used any CAR-T cell products or other genetically modified T cell therapies; * Previously received anti-tumor therapy against BCMA targets, including but not limited to antibodies, ADCs or CAR-T; * History of live vaccination (including live attenuated vaccines) within 4 weeks prior to signing the ICF; * Any non-hematologic toxicity due to prior therapy that cannot be restored to Grade ≤1 or baseline; * Patients with grade ≥2 acute graft-versus-host disease (GVHD) (Glucksberg criteria) or extensive chronic GVHD (Seattle criteria) requiring treatment within 4 weeks prior to enrollment, or those who may need to receive anti-GVHD treatment during the trial as judged by the investigator; * History of alcoholism, drug abuse or mental illness requiring drug intervention within 1 year prior to signing the ICF, which may affect the safety evaluation or compliance as judged by the investigator; * Other conditions that are considered inappropriate by the investigator to participate in this study.