BXCL701 Phase 1 R/R Acute Myeloid Leukemia or Myelodysplastic Syndrome

Must have received: hypomethylating agent (azacitidine, decitabine, oral decitabine/cedazuridine) — MDS-EB-2

Subjects with WHO defined myelodysplastic syndrome with excess blasts-2 (MDS-EB-2)...who are refractory or relapsed after at least 4 cycles of a hypomethylating agent (azacitidine, decitabine, or oral decitabine/cedazuridine)

Cannot have received: chemotherapy, other investigational therapy, immunotherapy, or radiotherapy

Exception: hydroxyurea is allowed with no required washout

Participants who have had chemotherapy, other investigational therapy, immunotherapy, or radiotherapy within 2 weeks or 5 half-lives from prior therapy, whichever is longer, prior to the first dose of study medication. Hydroxyurea is allowed with no required washout, and hydroxyurea may be administered for the first cycle of the protocol for patients who have proliferative disease (WBC <25K) with a maximum allowed dose of 6 g per day.

Cannot have received: oral tyrosine kinase inhibitor

Participants who have received oral tyrosine kinase inhibitors (TKIs) within two weeks or 5 half-lives (whichever is longer) of the first dose of study medication

Cannot have received: allogeneic bone marrow transplant

Subjects who are <100 days from allogeneic bone marrow transplant