Table 2 Ongoing clinical trials for TP53-mutated AML.
From: What have we learned about TP53-mutated acute myeloid leukemia?
Clinical Trial | Phase | Agent | Target/mechanism | Comments |
|---|---|---|---|---|
II | Flotetuzumab | Anti-CD3/CD123 | Bispecific DART; studied for R/R AML and MDS after allo-HSCT | |
Ib | APVO436 | CD3/CD123 | APVO436 + VEN + AZA for R/R AML or MDS | |
I/II | Entospletinib | SYK | Entospletinib + DEC in newly diagnosed TP53 mutant AML | |
I/II | Bexmarilimab | CLEVER-1 | In combination with AZA or AZA/VEN in MDS, CMML, and AML | |
I/II | ICT01 | BTN3A/CD477 | ICT01 + pembrolizumab in advanced stage R/R malignancies | |
I | Entrecitinib | ROS-1 | Entrecitinib + ASTX727 for R/R TP53 mutant AML. (ASTX727: DEC + cedazuridine) | |
Ia/b | Luxeptinib (CG-806) | BTK | For RR AML/high-risk MDS | |
I | NC525 | LAIR-1 | Open-label study for advanced myeloid neoplasms | |
I | ATO | Multiple targets | ATO + DAC for TP53 mutant high-risk MDS/AML | |
I | Atorvastatin | HMG Co-A reductase | Measuring change in conformational mutant TP53 | |
III | MBG453 (sabatolimab) | TIM-3 | MBG453 in combination with AZA in intermediate-, high-, and very-high–risk MDS per IPSS-R, or CMML-2 | |
I | Nivolumab | PD-1 | In combination with DEC and VEN in newly diagnosed TP53 mutated AML | |
I | Ipilimumab | CTLA-4 | Ipilimumab + DEC in R/R AML or MDS | |
I | CYAD-01 | NKG2D expressing CAR-T | THINK trial for multiple cancers | |
I | CART33 | CD33 CAR-T | For R/R CD33 positive AML | |
I | MB-102 | CD123 CAR-T | For R/R AML | |
I | ICG-144 | CLL1-CD33 CAR-T | In R/R high-risk hematologic malignancies |