Phase Ib Study of Anti-CD3 x Anti-CD33 Bispecific Antibody (CD33Bi) Armed Fresh Peripheral Blood Mononuclear Cells (CD33 FPBMC) in Patients With Measurable Residual Disease (MRD)+ Acute Myeloid Leukemia or Myelodysplastic Syndrome (AML-MDS 001)

NCT07270978 Phase 1 RECRUITING

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.

Details

Lead sponsor	University of Virginia
Phase	Phase 1
Status	RECRUITING
Enrolment	23
Start date	2026-03-26
Completion	2031-07

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Neoplasm

Interventions

• CD33 FPBMC

Primary outcomes

• DLTs — From start of treatment through 7 days after the 4th infusion (for each participant)
  Escalation phase participants only

Countries

United States