Novel antiamyloid agents in clinical trials for AL
| Agent . | Active clinical trials . | Study population . | Key endpoints . |
|---|---|---|---|
| EGCG | Randomized phase 2 | Cardiac involvement | Change in left ventricular mass at 12 mo |
| NCT02015312 | ≥ very good partial remission before therapy | ||
| EGCG | Randomized phase 2 | Cardiac involvement | Cardiac response by NT-proBNP at 6 mo |
| NCT01511263 | > partial remission before therapy | ||
| Doxycycline | Phase 2 | Newly diagnosed AL with vital organ (heart, kidney, liver) involvement | Amyloid organ response at 1 y |
| NCT02207556 | |||
| mAb 11-1F4 | Phase 1 | Relapsed refractory AL with measurable localized or vital organ involvement | Establish safety, maximum tolerated dose |
| NCT02245867 | Assess reduction in amyloid burden | ||
| mAb anti-SAP (GSK2398852) | Phase 1* | Systemic amyloidosis, multiple types | Establish safety and dose |
| NCT01777243 | Assess reduction in amyloid burden | ||
| mAb NEOD001 | Phase 1-2* | Previously treated AL with persistent organ damage | Establish safety and dose |
| NCT01707264 | Assess cardiac and renal responses | ||
| mAb NEOD001 | Phase 3 | Newly diagnosed untreated AL with cardiac involvement, NT-proBNP between 650 and 8500 ng/L | Time to composite of all-cause mortality or cardiac hospitalization |
| NCT02312206 | |||
| mAb NEOD001 | Randomized phase 2b | Previously treated AL with persistent cardiac dysfunction, NT-proBNP 650-5000 ng/L | Best cardiac response by NT-proBNP |
| NCT02632786 |
| Agent . | Active clinical trials . | Study population . | Key endpoints . |
|---|---|---|---|
| EGCG | Randomized phase 2 | Cardiac involvement | Change in left ventricular mass at 12 mo |
| NCT02015312 | ≥ very good partial remission before therapy | ||
| EGCG | Randomized phase 2 | Cardiac involvement | Cardiac response by NT-proBNP at 6 mo |
| NCT01511263 | > partial remission before therapy | ||
| Doxycycline | Phase 2 | Newly diagnosed AL with vital organ (heart, kidney, liver) involvement | Amyloid organ response at 1 y |
| NCT02207556 | |||
| mAb 11-1F4 | Phase 1 | Relapsed refractory AL with measurable localized or vital organ involvement | Establish safety, maximum tolerated dose |
| NCT02245867 | Assess reduction in amyloid burden | ||
| mAb anti-SAP (GSK2398852) | Phase 1* | Systemic amyloidosis, multiple types | Establish safety and dose |
| NCT01777243 | Assess reduction in amyloid burden | ||
| mAb NEOD001 | Phase 1-2* | Previously treated AL with persistent organ damage | Establish safety and dose |
| NCT01707264 | Assess cardiac and renal responses | ||
| mAb NEOD001 | Phase 3 | Newly diagnosed untreated AL with cardiac involvement, NT-proBNP between 650 and 8500 ng/L | Time to composite of all-cause mortality or cardiac hospitalization |
| NCT02312206 | |||
| mAb NEOD001 | Randomized phase 2b | Previously treated AL with persistent cardiac dysfunction, NT-proBNP 650-5000 ng/L | Best cardiac response by NT-proBNP |
| NCT02632786 |
Active, not recruiting