Acute myeloid leukemia is a cancer of the blood and bone marrow that progresses quickly and affects the production of normal blood cells. It is one of the major subtypes of acute leukemia and primarily affects adults and older adults.
The FDA granted Orphan Drug Designation to Cullinan Therapeutics’ CLN-049 for relapsed/refractory AML. CLN-049 is in Phase 1 studies and had already received Fast Track designation.
Senti Biosciences completed enrolment in its Phase I SENTI-202 trial in relapsed or refractory AML and said recent data showed deep, MRD-negative durable complete remissions. The company plans FDA talks in the first half of 2026 on a pivotal registration programme.
The FDA approved oral decitabine and cedazuridine tablets plus venetoclax for newly diagnosed AML in patients 75 and older or those ineligible for intensive induction chemotherapy. The approval was supported by phase 1/2 ASTX727-07 data showing a 41.6% complete response rate.
Moleculin said its MIRACLE Phase 2B/3 AML trial is nearing first unblinding, with blinded CRc above 40% and CR around 30%. The first 45-subject readout is expected before June 30, 2026.
The iPSC-derived NK cells pipeline includes 12+ active players and 15+ drugs in development. FT522 is in Phase I, while CNTY-101 and NCR300 are among other programs in the clinic.
Omeros reported initial nonhuman primate data for OncotoX-AML in acute myeloid leukemia. One treatment course reduced myeloid progenitor cells by up to 99% and was well tolerated.
Interim results from the ABC phase 1/2b trial show a calcineurin inhibitor-free GVHD prevention regimen combining posttransplant cyclophosphamide, bortezomib, and abatacept achieved low GVHD rates and favorable survival outcomes. The approach enables earlier introduction of posttransplant maintenance therapies while reducing toxicity associated with conventional immunosuppressants.
The FDA is set to make decisions on four drug applications in April 2026, including Orca-T for hematological malignancies, orforglipron for obesity, sparsentan for kidney disease, and a doravirine/islatravir combination for HIV-1.
The FDA approved acalabrutinib combined with venetoclax for chronic lymphocytic leukemia and small lymphocytic leukemia based on phase III trial results. Separately, Yale researchers identified CD25 protein complex as a new drug target for aggressive leukemias.
Faron Pharmaceuticals announces acceptance of bexmarilimab Phase I/II data for poster presentation at BSH 2026, while launching a new Phase II BEAM-X study evaluating the drug in AML patients post-stem cell transplantation.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07598110 |
FLUDARABINE-TREOSULFAN REDUCED INTENSITY CONDITIONING REGIMEN PRIOR HAPLOIDENTICAL STEM CELL TRANSPLANTATION WITH POST TRANSPLANTATION CYCLOPHOSPHAMIDE FOR OLDER AND/OR FRAIL PATIENTS WITH AML |
NOT_YET_RECRUITING | PHASE2 |
| NCT07584889 |
Efficacy and Safety of CD19-CAR.p40-T in Patients With Relapsed/Refractory CD19-Positive Hematologic Malignancies |
RECRUITING | PHASE1/PHASE2 |
| NCT07581002 |
A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07575412 |
SHR2554/AZA + Overlapped Modified BUCY for High-risk/Relapsed Leukemia/MDS |
NOT_YET_RECRUITING | PHASE2 |
| NCT07572929 |
A Pragmatic Clinical Trial to Prevent Relapse for Myeloid Malignancies With Measurable Disease Prior to Allogeneic Transplant |
NOT_YET_RECRUITING | PHASE2 |
| NCT07572695 |
Salvage Haploidentical HSCT With DLI and Targeted Therapy for R/R AML |
NOT_YET_RECRUITING | |
| NCT07570407 |
Quantification of Peripheral Blood iNKTs After Allogeneic Stem Cell Transplantation |
NOT_YET_RECRUITING | |
| NCT07570056 |
Use of Electrical Bioimpedance in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Patients (Bioimpedance) |
NOT_YET_RECRUITING | |
| NCT07563920 |
TBF Conditioning Regimen for Haploidentical Stem Cell Transplantation in Elderly AML Patients in First Complete Remission |
NOT_YET_RECRUITING | NA |
| NCT07563179 |
Bugitinib Combined With Venetoclax and Cytarabine in Relapsed/Refractory Acute Myeloid Leukemia |
RECRUITING | PHASE2 |
