BCMA CAR-T treatment for high-risk multiple myeloma patients

A Study of BCMA CAR-T for Dynamic High-risk Patients With Multiple Myeloma

This study is testing a new CAR-T cell therapy for people with high-risk multiple myeloma to see if it can help them after they’ve tried other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: CAR-T
• Locations: 1 site (Tianjin)
• Trial ID: NCT06880393 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label phase II study aimed at evaluating the efficacy and safety of BCMA CAR-T cell therapy in patients with dynamic high-risk multiple myeloma. Participants will receive BCMA CAR-T cell infusions following standard FC lymphoma deletion therapy. The study focuses on patients who have measurable disease and have undergone one line of standard anti-myeloma therapy. The goal is to determine how well this treatment works in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with measurable high-risk multiple myeloma who have received only one line of standard anti-myeloma therapy.

Not a fit: Patients who have not received any prior anti-myeloma therapy or those with low-risk multiple myeloma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with high-risk multiple myeloma, potentially improving their outcomes.

How similar studies have performed: Other studies have shown promising results with CAR-T therapies in hematological malignancies, indicating potential success for this approach.

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: 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.

Where this trial is running

Tianjin

• Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Gang An, PhD&MD

Conditions Multiple Myeloma