Table 1 Current clinical trials using antibody-drug conjugates 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT00766116 | A phase I/II trial of the combination 5-azacitidine and gemtuzumab ozogamicin therapy for treatment of relapsed AML | CD33 | Gemtuzumab ozogamicin | Azacitidine | I/II | Relapsed AML | Phase I: MTD; phase II: clinical response (CR rate) | 50 | University of California, San Diego | USA | 2005 | 2017 | Active, not recruiting |
NCT01902329 | A phase 1 trial of SGN-CD33A in patients with CD33-positive acute myeloid leukemia | CD33 | SGN-CD33A | Azacitidine or decitabine | I | Relapsed AML or newly diagnosed AML if not a candidate for intensive chemotherapy; CD33 expression | Toxicity | 195 | Seattle Genetics | USA | 2013 | 2017 | Active, not recruiting |
NCT02326584 | A phase 1b dose-escalation study of SGN-CD33A in combination with standard-of-care for patients with newly diagnosed acute myeloid | CD33 | SGN-CD33A | Standard of care | I | Newly diagnosed AML | Toxicity | 144 | Seattle Genetics | USA | 2014 | 2017 | Active, not recruiting |
NCT02674763 | A phase 1, multi-center, open-label study of IMGN779 administered intravenously in adult patients with relapsed/refractory CD33-positive | CD33 | IMGN779 | n.a. | I | r/r AML; CD33 expression | MTD | 124 | ImmunoGen | USA | 2016 | 2019 | Recruiting |
NCT02785900 | Vadastuximab talirine (SGN-CD33A; 33A) combined with azacitidine or decitabine in older patients with newly diagnosed acute myeloid leukemia (CASCADE) | CD33 | SGN-CD33A | azacitidine or decitabine | III | Newly diagnosed AML with non-favorable risk type; not a candidate for allogeneic HSCT | Clinical response (OS) | 500 | Seattle Genetics | USA, Australia, Korea, Taiwan, various European countries | 2016 | 2021 | Recruiting |
NCT02848248 | A phase 1 study of SGN-CD123A in patients with relapsed or refractory acute myeloid leukemia (AML) | CD123 | SGN-CD123A | n.a. | I | r/r AML; CD123 expression | Toxicity | 102 | Seattle Genetics | USA | 2016 | 2019 | Recruiting |