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

Main Inclusion Criteria:

• Diagnosis of R/RMM according to the IMWG criteria;

• Expected survival period is >12 weeks;

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2 at the timeof ICF signature;

• The expression of GPRC5D in bone marrow plasma cells membrane is more than 20% byflow cytometry and/or immunohistochemistry, multiple myeloma with measurablelesions, and at least one of the following criteria must be met:

1. Serum M protein >5 g/L;

2. Urine M protein level >200 mg/24 hour;

3. Serum free light chain (sFLC) >100 mg/L and K/λ FLC ratio is abnormal;

4. Primitive immature or monoclonal plasma cells >5% by bone marrow cytology orflow cytometry.

• Subjects who had received at least 3 prior lines of therapy including (but notlimited to) immunomodulatory drugs (IMiDs), proteasome inhibitors, anti-CD38monoclonal antibodies, etc., but have failed treatment, including those who haveexperienced relapse (within 12 months), refractory or intolerant to the last linetreatment regimen.

Main Exclusion Criteria:

• Smoldering myeloma (asymptomatic)

• Multiple myeloma with only extramedullary lesions;

• Plasma cell leukemia;

• Concurrent amyloidosis;

• Central nervous system metastasis, leptomeningeal disease or metastatic centralcompression;

• 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; CytomegalovirusDNA test is positive;

• Had hypersensitivity or intolerance to any drug/excipient (including conditioningchemotherapy) used in this study;

• Previously received treatment targeting GPRC5D, including but not limited toantibodies, 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 orleukapheresis requires parenteral antibiotic, antiviral, or antifungal treatment

• Major surgery within 28 days prior to Screening Visit with the exception of a biopsyand 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 affectcompliance with the protocol or make them unsuitable to participate in this study;

• Pregnant or breastfeeding.