Aponermin-Based Bridging Therapy Prior to CAR-T Infusion in Relapsed/Refractory Multiple M
This is a prospective, single-arm, multicenter, open-label study to evaluate the efficacy and safety of aponermin-based bridging therapy prior to CAR-T infusion in relapsed/refractory multiple myeloma patients with extramedullary disease.
| Condition(s) | Extramedullary Multiple Myeloma |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This is a prospective, single-arm, multicenter, open-label study to evaluate the efficacy and safety of aponermin-based bridging therapy prior to CAR-T infusion in relapsed/refractory multiple myeloma patients with extramedullary disease. |
| Who can participate | Inclusion Criteria: 1. Be informed and voluntarily sign the Informed Consent Form (ICF). 2. Age ≥18 years. 3. Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines) 4. Subjects with diagnosed relapsed or refractory extramedullary multiple myeloma according to IMWG criteria and have had at least 1 prior lines of therapy. Extramedullary disease (EMD) is defined as soft-tissue plasmacytomas NOT arising from skeletal lesions. The maximum diameter of extramedullary lesions should ≥2cm detected by physical exam and confirmed (when required) by Weight Bearing CT/MRI/PET-CT and/or biopsy. 5. ECOG score is ≤ 2 6. No active infections. 7. Negative for HBV-DNA, HCV-RNA, and HIV. 8. Liver function meeting the following criteria: Total bilirubin \<1.5 × ULN (patients with Gilbert's syn |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Locations | Beijing, China; Tianjin, China |
| Start date | 2025-04-09 |
| NCT ID | NCT06793475 |
| Official listing | https://clinicaltrials.gov/study/NCT06793475 |