CAR-T cell therapy targeting BCMA for treating multiple myeloma
A Clinical Study of the Safety and Efficacy of Chimeric Antigen Receptor-modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma
This study is testing a new CAR-T cell therapy that targets a specific protein to see if it can help people with hard-to-treat multiple myeloma feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Drugs / interventions | chimeric antigen receptor, CAR-T |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT06581640 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with relapsed or refractory multiple myeloma and confirmed BCMA expression in their myeloma cells.
Not a fit: Patients with significant comorbidities or those who do not express BCMA on their myeloma cells may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat multiple myeloma.
How similar studies have performed: Other studies utilizing CAR-T cell therapy targeting BCMA have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Xiamen, Fujian
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.