Status:
RECRUITING
BCMA CAR-T for Dynamic High-risk Multiple Myeloma
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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
Detailed Description
The study is a prospective, single-arm, single-centre, phase II study designed to evaluate the efficacy and safety of BCMA CAR-T in dynamic high-risk patients with multiple myeloma. Patients received ...
Eligibility Criteria
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
- Primary plasma cell leukemia.
- Concurrent amyloidosis.
- Involvement of the central nervous system (CNS).
- Previous treatment with BCMA-targeted therapy or CAR-T cell therapy.
- Disease progression or relapse within 3 months of autologous hematopoietic stem cell transplantation.
Key Trial Info
Start Date :
March 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06880393
Start Date
March 18 2025
End Date
March 1 2029
Last Update
August 3 2025
Active Locations (1)
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1
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China