CAR 70-BCMA CAR-T Cells for the Treatment of Relapsed or Refractory Plasma Cell Neoplasms

Inclusion Criteria15

• The subject or their legally authorized representative has provided written informed consent and is willing and able to comply with scheduled visits, study treatment, laboratory tests, and other study procedures
• Diagnosis of relapsed or refractory plasma cell neoplasms, defined as follows:
• Clonal plasma cells positive for BCMA and/or CD70 expression as determined by flow cytometry or immunohistochemistry
• Patients with multiple myeloma, plasmacytoma, or plasma cell leukemia who have received at least three prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody, and whose best response was less than partial response (PR) or who experienced disease progression after achieving at least PR
• Patients with systemic light chain amyloidosis who have received at least two prior lines of therapy, including an anti-CD38 monoclonal antibody and either a proteasome inhibitor (PI) or an immunomodulatory agent (IMiD), and whose best response was less than partial response (PR) or who experienced disease progression after achieving at least PR
• Aged 18 to 75 years (inclusive), male or female
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• Life expectancy greater than 3 months from the date of informed consent
• Hemoglobin (HGB) ≥ 60 g/L (transfusion permitted)
• Adequate hepatic, renal, cardiac, and pulmonary function meeting the following criteria:
• Creatinine ≤ 2 × upper limit of normal (ULN)
• Left ventricular ejection fraction (LVEF) ≥ 50%
• Oxygen saturation > 90%
• Total bilirubin ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
• The subject agrees to use contraceptive measures from the time of signing the informed consent form until 1 year after CAR-T cell infusion