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

The purpose of this study is to understand the safety and estimate the efficacy of combining anti-CD3 x anti-CD33 bispecific antibody (CD33Bi) armed fresh peripheral blood mononuclear cells (CD33Bi FPBMC) for patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) where they still have detectable disease ("MRD+") after some treatment. Participants receive 4 weekly doses of CD33 FPBMC by intravenous infusion followed by 4-6 weeks of standard treatment with a hypomethylating agent (type of treatment such as decitabine or azacitidine) and possibly a drug called venetoclax. This is considered 1 cycle of study treatment and may be repeated up to 4 times during the study.

NCT Number	NCT07270978
Lead Sponsor	University of Virginia
Conditions	Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm
Enrollment	23 participants
Start Date	2026-03-26
Primary Completion	2028-08 (estimated)
Study Completion	2031-07 (estimated)
Updated on ClinicalTrials.gov	2026-05-11