CAR-T cell therapy targeting BCMA for treating multiple myeloma

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 study evaluates the safety and tolerability of chimeric antigen receptor (CAR) gene-modified T cells that specifically target B-cell maturation antigen (BCMA) in patients with relapsed or refractory multiple myeloma. Eligible participants will undergo apheresis to collect peripheral blood mononuclear cells, which will be modified to create CAR-T cells and then transfused back into the patient. The study will follow participants for three years to assess the efficacy and safety of this innovative treatment approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-80 years, no gender restrictions;
2. Diagnosed with refractory/relapsed multiple myeloma through physical examination, pathological examination, laboratory tests, and imaging studies;
3. Flow cytometry or histology confirms positive BCMA expression in myeloma cells;
4. As judged by the investigator, the expected survival time is \>3 months;
5. ECOG performance status score ≤2, KPS \>60%;
6. The patient has good liver, kidney, heart, and lung function: ALT and AST ≤2.5×ULN, those with liver involvement can be relaxed to ≤5×ULN; serum total bilirubin \<34 μmol/L; creatinine clearance rate \>30 mL/min; heart ejection fraction (EF) ≥40%, no pericardial effusion and significant arrhythmia; indoor SpO2 ≥92%;
7. Peripheral blood lymphocyte absolute count ALC ≥0.5 ×10\^9/L, PLT \>30×10\^9/L, Hb \>80 g/L and has a single collection venous access, and there are no other contraindications for hematopoietic cell separation;
8. Those with fertility must agree to use highly effective contraceptive methods;
9. The subject or their legal guardian can understand and is willing to sign a written informed consent form voluntarily.

Exclusion Criteria:

1. Pregnant or nursing women, as well as women planning to become pregnant within the next six months;
2. Positive virology tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus;
3. History of other tumors (except for those with skin or cervical in situ cancers that have been cured by radical treatment and show no evidence of disease activity);
4. Previously received treatment targeting BCMA;
5. Underwent autologous hematopoietic stem cell transplantation within the last 6 weeks;
6. Presence of uncontrolled active bacterial or fungal infection;
7. Allergic to research-related drugs or cell components;
8. Presence of active autoimmune diseases;
9. Currently have unstable or active ulcers or gastrointestinal bleeding;
10. Unable to cooperate with treatment and efficacy evaluation due to mental or psychological disorders;
11. Received other experimental drug treatments within the last 3 months;
12. The researcher believes that for other reasons, the individual is not suitable for the clinical trial.

Where it's running

• The First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Recruiting

Study contacts

• Principal investigator: Bing Xu — The First Aiffiliated hosptical of xiamen University
• Study coordinator: Bing Xu
• Email: xubingzhangjian@126.com
• Phone: 18750918842

Similar studies

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

• In vivo CAR-T therapy for relapsed or refractory B‑cell leukemias, lymphomas, and multiple myeloma

  This trial will try a single in‑body (intravenous) CAR‑T infusion to treat adults with relapsed or refractory B‑cell acute lymphoblastic leukemia, B‑cell non‑Hodgkin lymphoma, or multiple myeloma.

  Recruiting Phase 1 Chongqing Precision Biotech Co., Ltd · Kunming, Yunnan · NCT07239323

• CG-105-12 treatment for relapsed or refractory multiple myeloma

  This study will test a single infusion of CG-105-12, an autologous BCMA-targeted CAR‑T therapy, in adults with BCMA-positive relapsed or refractory multiple myeloma who have had at least three prior treatments.

  Recruiting Early Phase 1 The First Affiliated Hospital of Nanchang University · Nanchang, Jiangxi · NCT06999031

• Geriatric assessment to improve recovery after CAR-T therapy for older patients with blood cancers

  This study is testing if personalized support and therapy can help older patients with blood cancers recover better after receiving CAR-T treatment.

  Recruiting at 4 sites Phase 2 City of Hope Medical Center · Duarte, California and 3 other locations · NCT06052826

• CAR-T Therapy Safety, Response, and Immune-Escape: Observational Study in Adults

  This observational study looks at adults who receive CAR-T cell therapy or bispecific antibodies to see which factors predict response and immune-related side effects.

  Recruiting IRCCS San Raffaele · Milan, Italy · NCT07915102

• 6MW5311 in adults with relapsed or refractory blood cancers

  This study tests increasing doses of 6MW5311 in adults with multiple myeloma, AML, or CMML to see if it is safe and tolerable and to find a suitable dose for later studies.

  Recruiting Phase 1 Mabwell (Shanghai) Bioscience Co., Ltd. · Shanghai, Shanghai Municipality · NCT07914556

• Tailored exercise program to improve quality of life for adults with hematologic cancers

  This pilot trial tests a personalized 16-week exercise program to see if it’s feasible and helpful for adults with acute myeloid leukemia, lymphoma, or multiple myeloma after first-line treatment.

  Recruiting Gruppo Italiano Malattie EMatologiche dell'Adulto · Roma, Rm and 2 other locations · NCT07912684

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.