Table 5 Targeting CD123 and other AML-associated target antigens: T-cell-recruiting bispecific antibodies.
From: T-cell-based immunotherapy of acute myeloid leukemia: current concepts and future developments
Clinicaltrials.gov identifier | AML target antigen | Study name | Drug name | Combination therapy? | Clinical phase | Indication | Primary end point | Estimated enrollment | Estimated completion date | Sponsor | Country | Status |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT02152956 | CD123 | Flotetuzumab in primary induction failure (PIF) or early relapse (ER) acute myeloid leukemia (AML) | Flotetuzumab (MGD006) | No | I | R/R AML, intermediate-2/high-risk MDS | DLT | 124 | 2020 | Macrogenics | USA, Germany, Netherlands | Recruiting |
NCT04158739 | CD123 | Flotetuzumab and cytarabine for the treatment of R/R AML | Flotetuzumab (MGD006) | Yes, with cytarabine | I | R/R AML (children, adolescents, and young adults) | DLT, toxicity | 47 | 2021 | Macrogenics | USA, Australia, Germany | Recruiting |
NCT02715011 | CD123 | A phase I, first-in-human, open-label, dose-escalation study of JNJ-63709178, a humanized CD123×CD3 DuoBody | JNJ-63709178 | No | I | R/R AML | DLT, toxicity | 60 | 2020 | Janssen Research & Development | Germany | Recruiting |
NCT02730312 | CD123 | A phase I multiple-dose study to evaluate the safety and tolerability of XmAb 14045 in patients with CD123-expressing hematologic malignancies | Xmab 14045 | No | I | Primary or secondary AML | MTD, toxicity | 66 | 2019 | Xencor | USA | Recruiting |
NCT03594955 | CD123 | First-in-human testing of dose-escalation of SAR440234 in patients with AML, ALL and MDS | SAR440234 | No | I/II | R/R AML | DLT, toxicity, ORR, DOR, EFS | 77 | 2022 | Sanofi | USA, Germany, Spain | Recruiting |
NCT03541369 | CD135 | Safety, tolerability, PK, PD, and efficacy of AMG 427 in subjects with R/R AML (20170528) | AMG 427 | No | I | R/R AML | DLT, TEAEs, TRAEs | 70 | 2022 | Amgen | USA, Australia, Canada | Recruiting |
NCT03038230 | CLL-1 | A phase I, multinational study of MCLA-117 in AML | MCLA-117 | No | I | R/R AML, newly diagnosed elderly untreated AML | DLT, toxicity | 50 | 2018 | Merus N.V. | Belgium, France, Italy, Netherlands | Recruiting |
