IL-15-Armored CAR-T Therapy in Relapsed or Refractory Multiple Myeloma and Plasma Cell Leukemia

Exclusion Criteria19

• History within 1 year prior to signing the informed consent form of any of the following:
• New York Heart Association (NYHA) Class III or IV heart failure;
• Myocardial infarction;
• Cardiac angioplasty or stent placement;
• Unstable angina;
• Other clinically significant symptomatic cardiac disease;
• Active graft-versus-host disease (GVHD) or requirement for systemic immunosuppressive therapy.
• History of other malignancies within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, or ductal carcinoma in situ of the breast after curative surgery.
• Active infection requiring systemic therapy or uncontrolled infection within 7 days prior to screening (excluding mild genitourinary or upper respiratory tract infections).
• Evidence of active viral or infectious disease as follows:
• Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA above the lower limit of detection;
• Positive hepatitis C virus (HCV) antibody with detectable HCV RNA;
• Positive human immunodeficiency virus (HIV) antibody;
• Positive Treponema pallidum particle agglutination assay (TPPA).
• Participation in another clinical trial within 4 weeks prior to signing the informed consent form, or if the time from the last dose of an investigational drug to informed consent is less than 5 half-lives of that drug (whichever is longer).
• History of severe allergic reactions to biologic products.
• Any unstable systemic disease, as judged by the investigator, including but not limited to severe hepatic, renal, or metabolic disorders requiring medical treatment.
• Pregnant or breastfeeding women; women planning to become pregnant within 2 years after cell infusion; or male participants whose partners plan to become pregnant within 2 years after cell infusion.
• Any condition that, in the opinion of the investigator, may increase the participant's risk or interfere with study participation or interpretation of study results.