Dual-target BCMA-GPRC5D CAR-T Cell Therapy for RR/MM With Extramedullary Infiltration

Exclusion Criteria

• •1. Pregnant or lactating women.
• •2. Active infections that have not been effectively controlled.
• •3. Active autoimmune diseases that have not been effectively controlled.
• •4. Adverse reactions caused by previous treatments have not recovered to CTCAE grade ≤ 1.
• •5. For allogeneic transplant patients, active graft - versus - host disease (GVHD) that has not been effectively controlled.
• •6. Presence of any of the following: HBV - DNA copy number above the lower limit of detection; positive hepatitis C antibody (HCV - Ab) with HCV - RNA copy number above the lower limit of measurability; positive anti - Treponema pallidum antibody (TP - Ab); positive human immunodeficiency virus (HIV) antibody test.
• •7. Allergic or intolerant to fludarabine or cyclophosphamide.
• •8. Suffering from known symptomatic non - plasma cell infiltrative central nervous system diseases.
• •9. Uncontrollable cardiovascular and cerebrovascular diseases within 6 months, such as: a. New York Heart Association (NYHA) class III or IV congestive heart failure. b. Myocardial infarction occurred or coronary artery bypass grafting (CABG) was received ≤ 6 months before enrollment. c. Clinically significant ventricular arrhythmia or a history of unexplained syncope (excluding cases caused by vasovagal or dehydration). d. A history of severe non - ischemic cardiomyopathy.
• •10. A history of other untreated malignancies within the past 5 years or having other untreated malignancies concurrently.
• •11. The investigator assesses that the subject cannot or is unwilling to comply with the requirements of the study protocol.
• •12. Previous use of a CAR - T vector with the same structure.