LMY-920 for Treatment of Relapsed or Refractory Myeloma
Since CAR-T cell treatment of refractory myeloma has shown success, based on preclinical data, we posit that CAR-T cells expressing B-cell activating factor (BAFF) can become another strategy to treat refractory myeloma, even after relapse following BCMA targeting CAR-T cell treatment. This will be phase 1 study of BAF
| Condition(s) | Multiple Myeloma, Refractory, Multiple Myeloma in Relapse |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | Since CAR-T cell treatment of refractory myeloma has shown success, based on preclinical data, we posit that CAR-T cells expressing B-cell activating factor (BAFF) can become another strategy to treat refractory myeloma, even after relapse following BCMA targeting CAR-T cell treatment. This will be phase 1 study of BAFF ligand CAR-T cells in relapsed and refractory myeloma. |
| Who can participate | Inclusion Criteria: 1. Subjects must have histologically confirmed myeloma relapsed or refractory after 3 or more lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Failing line of therapy is defined accordingly to International Myeloma Workshop Consensus Panel. 2. No evidence of CNS myeloma. 3. Male or female \> 18 years of age. 4. ECOG Performance status ≤ 2. 5. Has measurable disease at the time of enrollment as defined by at least one of the following: * Serum M-protein greater or equal to 0.5g/dL * Urine M-protein greater or equal to 200mg/24hr * Serum free light chain (FLC) assay: involved light chain greater or equal to 10mg/dL provided serum FLC ratio is abnormal * Bone marrow plasma cells greater than or equal to 30% total bone |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Luminary Therapeutics |
| Locations | Cleveland, Ohio, United States |
| Start date | 2024-03-13 |
| NCT ID | NCT05546723 |
| Official listing | https://clinicaltrials.gov/study/NCT05546723 |