Study of CT071 Injection in RRMM or PPCL

Exclusion Criteria

• •1. Pregnant or lactating females;
• •2. Patients with a history of neurological disease, such as epilepsy, intracranial hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, memory impairment, spinal cord compression, psychiatric disease or any disease involving the central nervous system, or suspected central nervous system (CNS) metastasis;
• •3. Patients with other incurable malignant tumors within 5 years or at the same time, except for those with very low degree of malignancy;
• •4. Patients with active autoimmune diseases, including but not limited to psoriasis, rheumatoid arthritis, inflammatory bowel disease and other patients requiring long-term immunosuppressive therapy;
• •5. Received allogeneic stem cell transplantation within two years prior to screening;
• •6. Received autologous stem cell transplantation within 12 weeks prior to screening, or plan to receive autologous stem cell transplantation during the trial;
• •7. Any uncontrolled disease or disorder with important clinical significance investigator considered not applicable for the study;
• •8. Patients who had any uncontrolled active infection (defined as the presence of persistent signs or symptoms associated with infection that did not improve despite appropriate antiinfective treatment) or who required intravenous antiinfective agents (except for prophylactic treatment) within 4 weeks before apheresis. If there is clinical indications, investigators should consider screening EBV, CMV, and other related pathogenic microorganisms;
• •9. Major surgery within 2 weeks prior to screening, or planning to undergo major surgery within 4 weeks after trial treatment (excluding cataract and other surgery under local anesthesia);
• •10. Received treatment for the disease under study within 2 weeks prior to apheresis(or within five half-lives of the drug, whichever is shorter), including but not limited to cytotoxic therapy, proteasome inhibitors, immunomodulators, targeted therapy, radiotherapy, epigenetic therapy, etc.; Received anti-PD-1/PD-L1 monoclonal antibody or other investigational drug/invasive medical device within 4 weeksprior to apheresis;
• •11. Vaccination with live attenuated vaccine or mRNA vaccine within 8 weeks and inactivated vaccine within 4 weeks before screening;
• •12. Patients who are allergic or intolerant to CLD drugs, tocilizumab, or allergic to the ingredients of CT071 cell infusion preparation (DMSO); Or previous history of other severe allergies, such as anaphylactic shock;
• •13. Positive test results for any of the following: human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, hepatitis C virus (HCV) RNA, hepatitis B virus (HBV) surface antigen (HBsAg), HBV DNA;
• •14. The toxicities caused by the previous treatment have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade 1, except for alopecia and other tolerable events as judged by the investigator;
• •15. Left ventricular ejection fraction (LVEF) \< 50%;
• •16. Oxygen saturation \< 92% at room air;
• •17. Received glucocorticoids within 7 days prior to apheresis, with the exception of inhaled glucocorticoids and physiologic replacement doses;
• •18. Other conditions considered inappropriate for participation in this clinical trial by the investigator.