Table 2.
Overview of ongoing clinical trials of antibodies for AML
| Antibody | Target | Regimen | Indication | Phase | Identifier |
|---|---|---|---|---|---|
| Antibodies targeting tumor-associated antigens | |||||
| BI 836858 | CD33 | BI 836858 + decitabine | AML | II | NCT02632721 |
| GO | CD33 | GO + CPX-351 | Relapsed AML | I | NCT03904251 |
| GO + venetoclax | R/R CD33 + AML | I | NCT04070768 | ||
| GO + pracinostat | R/R CD33 + AML | I | NCT03848754 | ||
| GO + allo-HCT | Average-risk CD33 + AML or MDS or JMML | I | NCT01020539 | ||
| GO, midostaurin, cytarabine and daunorubicin | Newly diagnosed FLT3 mutated AML | I | NCT03900949 | ||
| GO + talazoparib | R/R CD33 + AML | I/II | NCT04207190 | ||
| GO, midostaurin, cytarabine and daunorubicin | Newly diagnosed AML | I/II | NCT04385290 | ||
| GO, PF-04518600, venetoclax, avelumab, glasdegib and azacitidine | R/R AML | I/II | NCT03390296 | ||
| GO, G-CSF, cladribine, cytarabine and mitoxantrone | Newly diagnosed AML | I/II | NCT03531918 | ||
| GO | CD33 + AML | II | NCT03737955 | ||
| GO + allo-HCT | Average-risk CD33 + AML or MDS | II | NCT02117297 | ||
| GO + azacitidine | Newly diagnosed elderly AML | II | NCT00658814 | ||
| GO + bortezomib | R/R AML | II | NCT04173585 | ||
| GO + CPX-351 | R/R CD33 + AML or high-risk MDS | II | NCT03672539 | ||
| GO + DLI | R/R AML | II | NCT03374332 | ||
| GO, mitoxantrone and etoposide | Refractory CD33 + AML | II | NCT03839446 | ||
| GO, cyclophosphamide, busulfan and allo-HCT | High-risk CD33 + AML or MDS | II | NCT02221310 | ||
| GO, fludarabine, cytarabine, filgrastim-sndz and idarubicin | Newly diagnosed AML or high-risk MDS | II | NCT00801489 | ||
| GO, daunorubicin, cytarabine and glasdegib | Newly diagnosed AML | II | NCT04168502 | ||
| GO + standard chemotherapy | Pediatric AML | II | NCT04326439 | ||
| GO + cytarabine | Newly diagnosed AML | II/III | NCT02473146 | ||
| GO + daunorubicin + cytarabine | Elderly AML | II/III | NCT02272478 | ||
| GO | Newly diagnosed AML | III | NCT04093505 | ||
| GO + standard chemotherapy | Newly diagnosed NPM1 mutated AML | III | NCT00893399 | ||
| GO + standard chemotherapy + HCT | AML | III | NCT00049517 | ||
| GO, CPX-351, gilteritinib and standard chemotherapy | Newly diagnosed AML | III | NCT04293562 | ||
| GO, liposomal daunorubicin, mitoxantrone, fludarabine, cytarabine, busulfan and cyclophosphamide | Pediatric AML | III | NCT02724163 | ||
| GO | R/R CD33 + AML | IV | NCT03727750 | ||
| Lintuzumab Ac-225 | CD33 | Lintuzumab Ac-225, cladribine, cytarabine, mitoxantrone and G-CSF | R/R CD33 + AML | I | NCT03441048 |
| Lintuzumab-Ac225 + venetoclax + spironolactone | R/R CD33 + AML | I/II | NCT03867682 | ||
| Lintuzumab-Ac225 + venetoclax + azacitidine | R/R CD33 + AML | I/II | NCT03932318 | ||
| Daratumumab | CD38 | Daratumumab | R/R AML or high-risk MDS | II | NCT03067571 |
| Daratumumab + DLI | Relapsed AML after HCT | I/II | NCT03537599 | ||
| Isatuximab | CD38 | Isatuximab + standard chemotherapy | Pediatric R/R ALL or AML | II | NCT03860844 |
| Magrolimab | CD47 | Magrolimab + atezolizumab | R/R AML | I | NCT03922477 |
| Magrolimab + azacitidine | AML or MDS | I | NCT03248479 | ||
| Magrolimab + azacitidine + venetoclax | AML | I/II | NCT04435691 | ||
| Cusatuzumab | CD70 | Cusatuzumab, azacitidine and venetoclax | AML | I | NCT04150887 |
| Cusatuzumab + azacitidine | Newly diagnosed AML or high-risk MDS | I | NCT04241549 | ||
| Cusatuzumab + azacitidine | Newly diagnosed AML or high-risk MDS | I/II | NCT03030612 | ||
| Cusatuzumab + azacitidine | Newly diagnosed AML | II | NCT04023526 | ||
| SEA-CD70 | CD70 | SEA-CD70 | AML or MDS | I | NCT04227847 |
| IMGN632 | CD123 | IMGN632 | R/R CD123 + AML or other hematologic malignancies | I/II | NCT03386513 |
| IMGN632, venetoclax and azacitidine | CD123 + AML | I/II | NCT04086264 | ||
| ASP1235 | FLT3 | ASP1235 | AML | I | NCT02864290 |
| FLYSYN | FLT3 | FLYSYN | AML | I/II | NCT02789254 |
| Atezolizumab | PD-L1 | Atezolizumab + magrolimab | R/R AML | I | NCT03922477 |
| Atezolizumab + gilteritinib | R/R FLT3 mutated AML | I/II | NCT03730012 | ||
| Atezolizumab + guadecitabine | R/R AML, CML or MDS | I/II | NCT02935361 | ||
| Avelumab | PD-L1 | Avelumab, GO, PF-04518600, venetoclax, glasdegib and azacitidine | R/R AML | I/II | NCT03390296 |
| Durvalumab | PD-L1 | Durvalumab + azacitidine | Newly diagnosed MDS or elderly AML | II | NCT02775903 |
| Antibodies targeting NK cell inhibitory receptors | |||||
| Pembrolizumab | PD-1 | Pembrolizumab | Relapsed AML or MDS after HCT | I | |
| Pembrolizumab + decitabine | AML or MDS | I | NCT03969446 | ||
| Pembrolizumab + AMG 330 | R/R AML | I | NCT04478695 | ||
| Pembrolizumab | Non-favorable risk AML | II | NCT02771197 | ||
| Pembrolizumab | Elderly AML in remission | II | NCT02708641 | ||
| Pembrolizumab + cytarabine | R/R AML | II | NCT02768792 | ||
| Pembrolizumab + azacitidine | NPM1 mutated AML | II | NCT03769532 | ||
| Pembrolizumab + azacitidine | R/R AML or newly diagnosed elderly AML | II | NCT02845297 | ||
| Pembrolizumab, azacitidine and venetoclax | Elderly newly diagnosed AML | II | NCT04284787 | ||
| Pembrolizumab, cytarabine, idarubicin, daunorubicin and HCT | Newly diagnosed AML | II | NCT04214249 | ||
| Nivolumab | PD-1 | Nivolumab | High-risk AML or MDS after HCT | I | NCT04361058 |
| Nivolumab | Relapsed AML after HCT | I | NCT01822509 | ||
| Nivolumab + ipilimumab | AML or MDS | I | NCT02846376 | ||
| Nivolumab + ipilimumab | High-risk R/R AML or MDS | I | NCT03600155 | ||
| Nivolumab, CDX-1401, poly ICLC and decitabine | AML or MDS | I | NCT03358719 | ||
| Nivolumab + azacytidine | Pediatric R/R AML | I/II | NCT03825367 | ||
| Nivolumab | AML in remission at high-risk for relapse | II | NCT02532231 | ||
| Nivolumab | AML in remission | II | NCT02275533 | ||
| Nivolumab, azacitidine and ipilimumab | AML | II | NCT02397720 | ||
| Nivolumab, azacitidine, midostaurin, decitabine and cytarabine | Elderly newly diagnosed AML or high-risk MDS | II/III | NCT03092674 | ||
| Tislelizumab | PD-1 | Tislelizumab, DNA hypomethylating agent and chemotherapy | AML | II | NCT04541277 |
| Spartalizumab | PD-1 | Spartalizumab, MBG453 and decitabine | AML or high-risk MDS | I | NCT03066648 |
| Ipilimumab | CTLA-4 | Ipilimumab | Relapsed AML after HCT | I | NCT01822509 |
| Ipilimumab + nivolumab | High-risk R/R AML or MDS | I | NCT03600155 | ||
| Ipilimumab + nivolumab | AML or MDS | I | NCT02846376 | ||
| Ipilimumab + decitabine | R/R AML or MDS | I | NCT02890329 | ||
| Ipilimumab + DLI | Relapsed AML, MDS or MPN after HCT | I | NCT03912064 | ||
| Ipilimumab, nivolumab and azacitidine | AML | II | NCT02397720 | ||
| MBG453 | TIM-3 | MBG453, HDM201 and venetoclax | AML or high-risk MDS | I | NCT03940352 |
| MBG453, spartalizumab and decitabine | AML or high-risk MDS | I | NCT03066648 | ||
| MBG453, azacitidine and venetoclax | Newly diagnosed AML | II | NCT04150029 | ||
| BiKE or TriKE | |||||
| GTB-3550 | CD16/IL-15/CD33 | GTB-3550 | CD33 + R/R AML or high-risk MDS | I/II | NCT03214666 |
ALL acute lymphoblastic leukemia, allo-HCT allogeneic hematopoietic cell transplantation, AML acute myeloid leukemia, BiKE bi-specific killer cell engager, CML chronic myeloid leukemia, CTLA-4 cytotoxic T lymphocyte-associated antigen-4, DLI donor lymphocyte infusion, FLT3 FMS-like tyrosine kinase 3, G-CSF granulocyte colony-stimulating factor, GO gemtuzumab ozogamicin, HCT hematopoietic cell transplantation, JMML juvenile myelomonocytic leukemia, MDS myelodysplastic syndrome, MPN myeloproliferative neoplasm, NPM1 nucleophosmin 1, PD-1 programmed cell death-1, PD-L1 programmed cell death ligand-1, R/R relapsed/refractory, TIM-3 T-cell immunoglobulin domain and mucin domain-3, Treg regulatory T cell, TriKE tri-specific killer cell engager