Table 2 Current clinical trials using T cell-recruiting antibody constructs for immunotherapy of AML
From: Recent developments in immunotherapy of acute myeloid leukemia
Study identifier | Study name | Antigen/target | Drug name | Combination therapy | Clinical phase | Indication (AML only) | Primary endpoints | (Estimated) Enrollment | Sponsor | Country | Study start | (Estimated) Completion date | Status |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT02152956 | Phase 1, first in human, dose escalation study of MGD006, a CD123 × CD3 dual affinity re-targeting (DART®) bi-specific antibody-based molecule, in patients with relapsed or refractory AML or intermediate-2/high risk MDS | CD123 | MGD006 | No | I | r/r AML | DLT | 124 | Macrogenics | USA, France, Germany, Italy, Netherlands | 2014 | 2018 | Recruiting |
NCT02520427 | A phase 1 first-in-human study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of AMG 330 administered as continuous intravenous infusion in subjects with relapsed/refractory acute myeloid leukemia | CD33 | AMG 330 | No | I | r/r AML | DLT, toxicity | 50 | AMGEN | USA, Germany, Netherlands | 2015 | 2018 | Recruiting |
NCT02715011 | A phase 1, first-in-human, open-label, dose escalation study of JNJ-63709178, a humanized CD123 × CD3 DuoBody in subjects with relapsed or refractory AML | CD123 | JNJ-63709178 | No | I | r/r AML | DLT, toxicity | 60 | Janssen Research & Development | USA, Australia, Belgium, Germany | 2016 | Unknown | Suspended |
NCT02730312 | A phase 1 multiple dose study to evaluate the safety and tolerability of XmAb®14045 in patients with CD123-expressing hematologic malignancies | CD123 | Xmab14045 | No | I | Primary or secondary AML | MTD, toxicity | 66 | Xencor | USA | 2016 | 2018 | Recruiting |
NCT03038230 | A phase 1, multinational study of MCLA-117 in acute myelogenous leukemia | CLL-1 | MCLA-117 | No | I | r/r AML, newly diagnosed elderly untreated AML patients | DLT, toxicity | 50 | Merus N.V. | Belgium, France, Italy, Netherlands | 2016 | 2018 | Recruiting |