BCMA CAR-T for Dynamic High-risk Multiple Myeloma

Inclusion Criteria:

1. Be informed and voluntarily sign the Informed Consent Form (ICF).

2. Age between 18 and 75 years (inclusive).

3. Have measurable disease meeting at least one of the following criteria: SerumM-protein ≥1 g/dL (>10 g/L) as detected by serum protein electrophoresis (SPEP), orquantifiable IgA or IgD levels for IgA or IgD-type myeloma; Urine M-protein ≥200mg/24 hours; In cases where serum and urine M-protein do not meet the abovethresholds, an abnormal free light chain (FLC) ratio (normal range: 0.26 to 1.65)and involved serum FLC ≥100 mg/L.

4. Have received only one line of standard anti-myeloma therapy, including: Inductiontherapy with at least one proteasome inhibitor, one immunomodulatory agent, andcorticosteroids; Sequential autologous hematopoietic stem cell transplantation orconsolidation therapy; Maintenance therapy based on either a proteasome inhibitor oran immunomodulatory agent.

5. Meet at least one of the following dynamic high-risk criteria: Early relapse:Disease progression or relapse within 18 months of starting first-line therapy,including progression or relapse within 12 months post-autologous hematopoietic stemcell transplantation; Primary refractory disease: Failure to achieve at leastminimal response (MR) after four cycles of induction therapy; Relapse with newgenetic abnormalities: Gain(1q), del(17p), or TP53 mutation.

6. Confirmed expression of the BCMA target antigen on MM cells by flow cytometry orbone marrow immunohistochemistry.

Exclusion Criteria:

1. Primary plasma cell leukemia.

2. Concurrent amyloidosis.

3. Involvement of the central nervous system (CNS).

4. Previous treatment with BCMA-targeted therapy or CAR-T cell therapy.

5. Disease progression or relapse within 3 months of autologous hematopoietic stem celltransplantation.