BCMA CAR-T for Dynamic High-risk Multiple Myeloma
This study tests a new treatment called BCMA CAR-T for multiple myeloma patients at high risk of their disease getting worse. CAR-T is a type of therapy that uses your own immune cells, which are genetically modified in the laboratory to better fight cancer cells.
Key Objective:This trial is testing whether BCMA CAR-T can effectively control multiple myeloma and improve outcomes in patients whose disease is considered high-risk.
Who to Consider:Patients with multiple myeloma who are at high risk of disease progression and have exhausted standard treatment options may want to consider enrolling in this study.
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
This is a single-arm, open-label study to evaluate the efficacy and safety of BCMA CAR-T in dynamic high-risk patients with multiple myeloma
Eligibility Criteria
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: Serum M-protein ≥1 g/dL (\>10 g/L) as detected by serum protein electrophoresis (SPEP), or quantifiable IgA or IgD levels for IgA or IgD-type myeloma; Urine M-protein ≥200 mg/24 hours; In cases where serum and urine M-protein do not meet the above thresholds, 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: Induction therapy with at least one proteasome inhibitor, one immunomodulatory agent, and corticosteroids; Sequential autologous hematopoietic stem cell transplantation or consolidation therapy; Maintenance therapy based on either a proteasome inhibitor or an immunomodulatory agent. 5. Meet at least one of the following dynamic high-risk criteria: Ea