Table 2. Clinical trials involving bispecific antibodies in AML.
Name | Format | Phase | Endpoint | Clinical trial number | Sponsor | Study population | Status |
---|---|---|---|---|---|---|---|
JNJ-63709178 | CD123 × CD3 DuoBody | 1 | Safety and efficacy | NCT02715011 | Janssen Research & Development, LLC | Relapsed/refractory AML | Suspended |
AMG 330 | CD33 × CD3 Tandem scFv (BiTE) | 1 | Safety | NCT02520427 | Amgen | Relapsed/refractory AML | Suspended |
MGD006 | CD123xCD3 DART | 1 | Safety | NCT02152956 | MacroGenics | Relapsed/refractory AML, MDS | Recruiting |
Abbreviations: AML, acute myeloid leukemia; BiTE, bispecific T-cell engager; DART, dual-affinity re-targeting; MDS, myelodysplastic syndrome.
DuoBody (Genmab, Copenhagen, Denmark) is the commercialized name of the controlled Fab-arm exchange (cFAE) platform to generate IgG1 monovalent bispecific antibodies.145