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

This is a single-arm, open-label study to evaluate the efficacy and safety of VRD-based Regimen (Bortezomib, Lenalidomide and Dexamethasone) combined with CART-ASCT-CART2 in Chinese patients with newly diagnosed primary plasma cell leukemia.

Inclusion Criteria: 1. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. 2. Age ≥ 18 years and ≤ 65 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. 4. Life expectancy at least 3 months 5. Definitive diagnosis of pPCL: meet the diagnosis criteria of multiple myeloma (refer to the Chinese guidelines for the diagnosis and management of multiple myeloma (revised 2022) criteria) and meeting any of the following: 1. the proportion of tumor plasma cells in peripheral blood leukocytes ≥ 5%; 2. absolute value of peripheral blood tumorigenic plasma cells exceeds 2×10\^9/L. 6. Patients have not received previous anti-myeloma related therapy. 7. Measurable disease, as defined by at lease one of the following: 1. Serum monoclonal paraprotein (M-protein) level ≥5g/L. 2. urine M-protein level ≥200 mg/24 hours. 3. If the serum and urine M-protein are unmeasurable, abnormal serum free light chain (FLC) ratio and affected FLC ≥10 mg/dL. 8. Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination. 9. Routine blood tests (performed within 7 days, no RBC transfusion, no G-CSF/GM-CSF/platelet agonists, no drug correction within 14 days before screening, no PLT transfusion within 7 days) : ANC ≥ 1.0 x 10\^9/L, PLT ≥ 50 x 10\^9/L. 10. All screening blood biochemistry: tests should be performed according to the protocol and within 14 days before enrollment. Screening laboratory values must meet the following criteria: 1. Total bilirubin\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) \