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Clinical Trials in China / NCT06880393
Recruiting Phase 2

BCMA CAR-T for Dynamic High-risk Multiple Myeloma

NCT06880393 · tracked via the Priya Life Science China tracker
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 2
Started
2025-03-18
Last updated
2025-08-03

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

anti-BCMA-CAR-T →

anti-BCMA-CAR-T: Autologous BCMA-directed CAR-T cells, infusion intravenously at a target dose of 2.0-4.0 x 10\^6 anti-BCMA CAR+T cells/kg

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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: 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. 6. Confirmed expression of the BCMA target antigen on MM cells by flow cytometry or bone 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 cell transplantation.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences Tianjin China Recruiting

More Institute of Hematology & Blood Diseases Hospital, China trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06880393 on ClinicalTrials.gov ↗ ← All trials in China