Background
Biology of NK cells
Dysfunction of NK cell-mediated anti-leukemia responses in patients with AML
NK cell-based immunotherapy in AML
Adoptive NK cell transfer
Adoptive NK cell transfer in the context of HCT
Adoptive NK cell transfer in the non-HCT setting
Identifier | Phase | Indication | In vivo cytokine | Transplantation | Outcome measure |
---|---|---|---|---|---|
PBMC-derived NK cell infusion | |||||
NCT04221971 | I | R/R AML | None | No | AE, response, NK cell metabolism, migration and reconstruction, cell count recovery, relapse |
NCT04220684 | I | R/R AML or MDS | None | No | MTD, AE, response, survival, cell count recovery, number of patients able to proceed to HCT |
NCT04209712 | I | AML with MRD | IL-2 | No | MRD, AE |
NCT02890758 | I | AML, MDS, et al | ALT-803 | No | AE, response, survival, in vivo NK level |
NCT01787474 NCT02809092 | I/II | R/R AML | None | No | MTD, response, NK cell expansion |
NCT03300492 | I/II | AML or MDS | None | Days + 10, + 15 and + 20 post-HCT | AE, survival, response, NK cell dose |
NCT01823198 | I/II | High-risk AML or MDS | IL-2 | Day -8 pre-HCT | Optimal NK cell dose, survival, AE |
NCT01904136 | I/II | AML, MDS or CML | None | Days 7 and 28–90 post-HCT | MTD, AE, survival, time to engraftment |
NCT04395092 | II | High-risk AML or MDS | None | Days—2, + 7 and + 28 post-HCT | Relapse, AE, survival |
NCT04166929 | II | AML or MDS | None | Day + 7 post-HCT | Relapse |
NCT03050216 | II | R/R AML | ALT-803 | No | Response, NK cell expansion, AE |
NCT03955848 | NA | AML in remission | IL-2 | No | Survival |
Placental-derived HSPC-NK cell (CYNK-001) infusion | |||||
NCT04310592 | I | AML | None | No | MTD, AE, MRD, survival |
UCB-derived HSPC-NK cell infusion | |||||
NCT01619761 | I | AML, MDS, et al | None | Day-2 pre-CBT | AE, survival |
NCT04347616 | I/II | R/R AML | IL-2 | No | AE, MRD, NK cell lifespan, expansion and functional activity, plasma cytokine concentration, number of patients able to proceed to HCT |
NCT02727803 | II | AML, MDS, et al | None | Days 30–180 post-CBT | Survival, AE |
iPSC-derived NK cell (FT516) infusion | |||||
NCT04023071 | I | R/R AML or B-cell lymphoma | IL-2 | No | AE, response, pharmacokinetic data |
Cytokine-induced memory-like NK cell infusion | |||||
NCT03068819 | I | Relapsed AML after HCT | None | No | AE, response, survival |
NCT04024761 | I | Relapsed AML, MDS or MPN after HCT | IL-2 | No | AE, response, survival |
NCT01898793 | I/II | R/R AML or MDS | IL-2 | No | MTD, response, AE, survival |
NCT04354025 | II | R/R AML | IL-2 | No | Response, number of patients able to proceed to HCT, survival, MRD, AE |
NCT02782546 | II | R/R AML | ALT-803 | Day + 7 post-HCT | Survival, response |
CMV-induced memory-like NK cell (FATE-NK100) infusion | |||||
NCT03081780 | I | R/R AML | IL-2 | No | MTD, response, NK cell expansion, AE, MRD, survival |
CAR-NK cell therapy
Antibodies
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 | NCT03286114 NCT02981914 |
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 |