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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Gang An, PhD&MD
• Email: angang@ihcams.ac.cn
• Phone: 86-022-23909171

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BCMA-TGFβ CAR-T Cells in Relapsed or Refractory Myeloma

  A one-arm phase 1 study tests a new BCMA-TGFβ CAR-T cell therapy to see if it is safe and provides signs of benefit in adults whose multiple myeloma has come back or persisted after prior treatments.

  Recruiting Phase 1 Medical College of Wisconsin · Milwaukee, Wisconsin · NCT05976555

• CAR-T therapy outcomes and quality of life in older adults with B‑cell lymphoma

  This project will see how CAR‑T therapy affects older adults (age 60+) with relapsed or refractory B‑cell lymphomas, focusing on daily function and quality of life while they receive standard care.

  Recruiting Memorial Sloan Kettering Cancer Center · New York, New York · NCT04300998

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• Understanding CAR-T Toxicities After Cilta-Cel in Multiple Myeloma

  This observational study tests how patients with multiple myeloma respond to cilta-cel treatment by tracking toxicities and trying to spot biomarkers to guide care.

  Recruiting at 3 sites Icahn School of Medicine at Mount Sinai · San Francisco, California and 2 other locations · NCT07665307

• PD-1Ab21-BCMA CAR-T consolidation for multiple myeloma with renal dysfunction

  This trial will test a BCMA-targeted CAR-T cell therapy that secretes a PD-1 antibody and interleukin-21 fusion protein as consolidation treatment for people with multiple myeloma who have kidney dysfunction.

  Recruiting Phase 2 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07489534

• DC/MM fusion vaccine plus BCMA CAR-T for relapsed or refractory multiple myeloma

  This trial will test whether adding a personalized DC/MM fusion vaccine (with GM‑CSF) to standard BCMA CAR‑T therapy helps people with relapsed or refractory multiple myeloma.

  Recruiting Phase 1 Beth Israel Deaconess Medical Center · Boston, Massachusetts · NCT07377435

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.