A Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Primary Plasma Cell Leukemia

Exclusion Criteria

• •1. Secondary plasma cell leukemia.
• •2. With central nervous system (CNS) involvement.
• •3. Ineligible for autologous stem cell transplantation, such as severe cardiopulmonary disorders.
• •4. Known intolerant, allergic, or resistant to glucocorticoids, bortezomib, lenalidomide, Venetoclax, Selinexor and BCMA-CART cellular products.
• •5. Patients had major surgery within 2 weeks before randomization (for example, general anesthesia), or is not fully recovered from the surgery, or surgery is arranged during study period.
• •6. Patients with unstable or active cardiovascular system disease, meeting any of the following:
• •1. Unstable angina pectoris, symptomatic myocardial ischaemia, myocardial infarction or coronary artery reconstruction within 180 days prior to the first dose.
• •2. Uncontrolled hypertension (\>140/90 mmHg with blood pressure fluctuations of more than 180/100 mmHg over a 6-month period).
• •3. Uncontrolled and clinically significant conduction abnormalities (e.g. patients with ventricular arrhythmias controlled by antiarrhythmic medication), not excluding patients with 1st degree atrioventricular (AV) block or asymptomatic left anterior bundle branch block/right bundle branch block (LAFB/RBBB)).
• •4. Congestive heart failure (CHF) classification ≥ grade 3 as defined by the New York Heart Association (NYHA).
• •5. Left ventricular ejection fraction (LVEF) \<50% on echocardiography.
• •6. History of stroke or intracranial haemorrhage within 12 months prior to screening.
• •7. Presence of a serious thrombotic event prior to treatment.
• •7. Known positive serology for HIV or HIV seropositivity.
• •8. Active hepatitis B or C infection. Screening requires serologic testing for hepatitis. If hepatitis B surface antigen and hepatitis B core antibody were positive, a negative DNA polymerase chain reaction (PCR) result was needed before enrollment (after anti-hepatitis B therapy, a negative DNA polymerase PCR result was confirmed before enrollment). If the hepatitis C antibody was positive, the RNA PCR test should be negative prior to enrollment.
• •9. Ongoing active infection.
• •10. Prior history of malignancies, unless free of the disease for ≥ 5 years.
• •11. Pregnant or breast feeding females.
• •12. Any active gastrointestinal dysfunction that affects the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that may affect the absorption of the studied treatment medication.
• •13. According to the researcher's judgment, any condition including but not limited to serious mental illness, medical illness, or other symptoms/conditions that may affect study treatment, compliance, or the capability of providing informed consent.
• •14. Necessary medication or supportive therapy is contraindicated with study treatment.
• •15. Any other medical condition or comorbidity that might interfere with subject's participation.
• •16. Patients undergoing other experimental therapies.
• •17. Patients are not willing to or cannot comply with study scheme.