BCMA CAR-T Cell Therapy for High-risk Multiple Myeloma
Tests BCMA CAR-T cell therapy in adults with high-risk multiple myeloma.
Plain-language title generated from the registry record
Registry title: BCMA CAR-T for Dynamic High-risk Multiple Myeloma
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06880393, who can take part
Where in China
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical SciencesTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT06880393
- Record updated
- 3 August 2025
- Original description
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 myelomaRead full original descriptionShow less
A Study of BCMA CAR-T for Dynamic High-risk Patients With Multiple Myeloma
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
Inclusion: Be informed and voluntarily sign the Informed Consent Form (ICF); Age between 18 and 75 years (inclusive); 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; 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; 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 stem cell transplantation; Primary refractory disease: Failure to achieve at least minimal response (MR) after four cycles of induction therapy; Relapse with new genetic abnormalities: Gain(1q), del(17p), or TP53 mutation; Confirmed expression of the BCMA target antigen on MM cells by flow cytometry or bone marrow immunohistochemistry.
Exclusion: Concurrent amyloidosis; Previous treatment with BCMA-targeted therapy or CAR-T cell therapy; Disease progression or relapse within 3 months of autologous hematopoietic stem cell transplantation; Primary plasma cell leukemia; Involvement of the central nervous system (CNS).