A Phase I Clinical Trial of Y150 in the Treatment of Relapsed or Refractory Multiple Myeloma

Exclusion Criteria

• •1. Subject has central nervous system involvement of multiple myeloma.
• •2. Subject has received ≥ 10 mg/day prednisone equivalent within one week before starting Y150.
• •3. Subject with primary or secondary plasma cell leukemia.
• •4. Subject had a prior autologous stem cell transplant ≤ 12 weeks months prior to starting Y150, or had a prior autologous stem cell transplant history.
• •5. Subject received a chimeric antigen receptor T (CAR T) cell product ≤ 6 months prior to starting Y150.
• •6. Concurrent malignancy within 5 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer under active surveillance, prostate cancer that has undergone definitive treatment, ductal carcinoma in situ of the breast, or ≤ T1 urothelial carcinoma.
• •7. Allergy to Abs drugs or human protein.
• •8. Active infection(CTCAE Grade ≥2).
• •9. Subjects with severe respiratory disease, and to be unsuitable to participate in study by investigators judgment.
• •10. Severe cardiovascular disease, including a history of CABG or PCI, myocardial infarction within 6 months of study entry, unstable angina ,NYHA class III or IV heart failure, uncontrolled hypertension or left ventricular ejection fraction \<50%
• •11. QTc interval \> 480 ms; Family or personal with a history of long or short QT syndrome; significant clinical history of ventricular arrhythmias, or currently receiving antiarrhythmic drugs or implanted defibrillator to treat ventricular arrhythmias.
• •12. Patients with a history of active autoimmune diseases (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis etc.), except when the disease is in a stable state (without systemic immunosuppressant treatment, the symptoms are stable for more than 6 months).
• •13. Patients with severe hyperthyroidism or hypothyroidism.
• •14. Patients with metabolic diseases such as uncontrolled diabetes, severe gastrointestinal bleeding, severe diarrhea (Grade ≥ 2 according to CTCAE), or severe gastrointestinal obstruction requiring intervention.
• •15. Patients with a history of immunodeficiency, including HIV positive.
• •16. HIV antibody, TP antibody and HCV antibody were positive, HBsAg positive and hepatitis B virus DNA test showed that patients with active hepatitis B (HBV-DNA ≥ 1000cps/ml).
• •17. Patients who have received inoculation of (attenuated) live virus vaccine within 4 weeks before the first administration.
• •18. Pregnant, lactating women, or females or males who have fertility plan within 6 months during the study and after the end of the medication.
• •19. Patients with a previous history of definite neurological or psychiatric disorders, and investigator believe that it affects patients' cognitive function or compliance, including unstable epilepsy, dementia, schizophrenia, etc.
• •20. Any condition that the investigator believes may not be appropriate for participating the study.