To Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With R/R MM or PCL

Korábbi kezelés

• Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
• Received CAR-NK treatment or other gene therapies before enrollment;
• Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;

Más betegség

• Accompanied by other uncontrolled malignancies;
• Subjects with positive Hepatitis B surface antigen(HBsAg) or Hepatitis B core antibody (HBcAb) and hepatitis B virus (HBV) DNA titers higher than the lower limit of the normal range of the investigative site; Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human Immunodeficiency Viral (HIV) antibody positive; syphilis primary screening antibody positive;
• Subjects who have a disease that affects the signing of written informed consent or who are unable to comply with research procedures; or who are unwilling or unable to comply with research requirements;
• Subjects who have had severe immediate hypersensitivity reactions to any drugs used in this research;
• In the past two years, the terminal organ was damaged due to autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or the systemic use of immunosuppressive or other systemic disease control drugs was required;

Egyéb

• Subjects who are considered unsuitable to participate in this trial by the investigator.
• Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
• Patients with symptoms of central nervous system.

• Subjects volunteer to participate in clinical trials, understand and sign the informed consent document, be willing to complete all the trial procedures;
• 18 years and older, Male and female;
• Expected survival > 12 weeks;
• Documented evidence of multiple myeloma at diagnosis as defined by IMWG updated criteria (2014), or plasma cell leukemia at diagnosis as defined by Diagnosis and therapeutic criteria of hematologic disease (4th edition);
• One of the following indicators is satisfied:
  • Serum M protein: IgG M protein ≥5 g/L; or IgA M protein ≥5 g/L; or IgD M protein and IgD >ULN;
  • Urine M protein ≥200 mg/24h;
  • Affected serum free light chain ≥100 mg/L and Serum free light chain ratio is abnormal;
  • Clonal bone marrow plasma cells ≥10 % for non-secretory myeloma;
• Patients with relapsed/refractory multiple myeloma or plasma cell leukemia, satisfying:
  • Patients have received at least 3 prior MM or PCL treatment regimens containing at least one proteasome inhibitor and one immunomodulatory;
  • Progress is documented within 60 days of the most recent anti-tumor treatment, or efficacy assessment does not reach minimal response(MR) or above;
• Liver, kidney and cardiopulmonary functions meet the following requirements:
  • Creatinine clearance rate (estimated by CockcroftGault formula) ≥30mL/min;
  • Left ventricular ejection fraction > 50%;
  • Baseline peripheral oxygen saturation > 95%;
  • Total bilirubin≤ 2×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN;
• Blood routine examination satisfying hemoglobin≥60 g/L, neutrophils≥ 1.0×10\^9/L, and platelets≥30×10\^9/L, can complete this trial according to the judgement of investigators.