Phase Ib Study of CD33 FPBMC in Patients With MRD+ AML or MDS

Inclusion criteria

• ✓. Newly diagnosed or relapsed/refractory AML who have received either intensive induction chemotherapy or at least 2 cycles of a non-intensive options such as hypomethylating agent and venetoclax or other targeted agent
• ✓. Relapsed/ refractory (R/R) MDS who have received at least 2 prior cycles of hypomethylating agent and venetoclax or single agent hypomethylating agent for at least 4 cycles
• ✓. Relapsed/refractory (R/R) MDS/MPN overlap syndromes like CMML who have received at least 2 prior cycles of azacitidine and venetoclax or single agent hypomethylating agent for at least 4 cycles 3. For patients with targetable mutations (IDH1, IDH2, KMT2A, or FLT3): Receipt of and/or decision not to receive associated inhibitor.
• ✓. Bone marrow blasts ≥ 5%
• ✓. Appearance of previously absent leukemic blasts in peripheral blood
• ✓. Absolute neutrophil count \<1 x 109/L and 50% below best unsupported on-study value
• ✓. Platelet count \<100 x 109/L and 50% below best unsupported on-study value
• ✓. Hemoglobin \<11g/dL, and ≥2 g/dL reduction from best unsupported on-study value

Exclusion criteria