Table 1.
Clinical trials with innovative mAbs in AML.
| NCT Code | Trial | Target | Study Population | Efficacy Results | Ref. |
|---|---|---|---|---|---|
| NCT03248479 | Ongoing phase Ib, magrolimab + AZA | CD47 | untreated AML unfit for induction chemotherapy. | ORR 69%: 50% CR or CRi, 13% PR and 31% SD | [18] |
| NCT02678338 | Phase I, magrolimab | CD47 | R/R AML | N/A | [19] |
| NCT04755244 | Ongoing phase I/II, evorpacept + venetoclax + AZA | CD47 | R/R AML ineligible for standard induction chemotherapy | N/A | N/A |
| NCT01822509 | Phase I/Ib, ipilimumab | CTLA-4 | R/R AML after allogeneic HSCT | Durable response (>1 year): 4/22 | [20] |
| NCT02397720 | Ongoing phase II, nivolumab + AZA | PD-1 | R/R AML | ORR: 33% mOS: 10.6 months |
[21] |
| NCT02530463 | Ongoing phase II, ipilimumab + nivolumab + AZA vs. nivolumab + AZA vs. AZA | PD-1 | R/R AML | Ipilimumab + nivolumab + AZA arm: mOS 7.6 months; Nivolumab + AZA arm: mOS 5.9 months; AZA control arm: mOS 4.4 months |
[22] |
| NCT03066648 | Phase Ib, sabatolimab +/− PDR001 + HMA | TIM-3 | AML | ND AML unsuitable for induction chemotherapy: ORR 41.2%, CR 8%, CRi 3%, PR 3% | [23] |
| NCT02785900 | Phase III, vadastuximab talirine + AZA/decitabine vs. placebo | CD33 | Older ND AML | Terminated (due to poor safety) | [24,25] |
| NCT02575963 | Phase II, 225 Ac-lintuzumab | CD33 | AML | 69% remission | [26] |
| NCT02520427 | Ongoing phase I, AMG330 | CD33 | R/R AML | CR/CRi 11.4% | [27] |
| NCT03647800 | Phase IB, APVO436 | CD123 | R/R AML | N/A | [28] |
| NCT02730312 | Ongoing phase I, vibecotamab | CD123 | R/R AML | CR/CRi: 23% | [29] |
| NCT03386513 | Ongoing phase I/II, IMGN632 | CD123 | R/R AML | CR: 1/12, CRi: 3/12 | [30] |
| NCT03113643 | Ongoing phase I, tagraxofusp + AZA vs. AZA/venetoclax | CD123 | AML | N/A | [31] |
| NCT02152956 | Ongoing phase I/II, flotetuzumab | CD123 | R/R AML | ORR 13.6%, CR 11.7% | [32] |
| NCT00008177 | Phase I, iomab-B + FLU + 2 Gy TBI | CD45 | Over 50 years AML | N/A | [33] |
| NCT02665065 | Ongoing phase III, iomab-B + FLU + low-dose TBI | CD45 | R/R AML | N/A | [33] |
| NCT01300572 | Phase I, 90Y-BC8 + FLU/TBI | CD45 | AML ineligible for allogeneic HSCT | OS at 1.8 years: 53% | [34] |
| NCT03030612 | Phase I/II, cusatuzumab monotherapy followed by cusatuzumab + AZA | CD70 | Untreated older AML | CR/CRi: 83% | [35] |
AZA, azacytidine; AML, acute myeloid leukemia; ORR, overall response rate; CR, complete remission; CRi, complete response with incomplete hematologic recovery; PR, partial response; SD, stable disease; R/R, relapsed/refractory; HSCT, hematopoietic stem cells transplant; mOS, median overall survival; HMA, hypomethylating agents; ND, newly diagnosed; FLU, fludarabine; TBI, total body irradiation; OS, overall survival.