OriCAR-017 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of R/RMM

Exclusion Criteria

• •Smoldering myeloma (asymptomatic)
• •Multiple myeloma with only extramedullary lesions;
• •Plasma cell leukemia;
• •Concurrent amyloidosis;
• •Central nervous system metastasis, leptomeningeal disease or metastatic central compression;
• •HBsAg or HbcAb is positive, and the quantitative detection of hepatitis B virus (HBV) DNA in peripheral blood is more than 100 copies/L; hepatitis C virus (HCV) antibody and HCV RNA in peripheral blood is positive; human immunodeficiency virus (HIV) antibody positive; syphilis antibody is positive at Screening; Cytomegalovirus DNA test is positive;
• •Had hypersensitivity or intolerance to any drug/excipient (including conditioning chemotherapy) used in this study;
• •Previously received treatment targeting GPRC5D, including but not limited to antibodies, ADC, or CAR-T;
• •Subjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study;
• •Any uncontrolled active infection within 4 weeks prior to ICF signing or leukapheresis requires parenteral antibiotic, antiviral, or antifungal treatment
• •Major surgery within 28 days prior to Screening Visit with the exception of a biopsy and an insertion of a central venous catheter or during the study;
• •Subjects who received allogeneic stem cell therapy;
• •Subjects complications or other conditions evaluated by investigators may affect compliance with the protocol or make them unsuitable to participate in this study;
• •Pregnant or breastfeeding.