RecruitingPhase 1NCT07270978

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

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

Sponsor

University of Virginia

Enrollment

23 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasm

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy called CD33 FPBMC in patients with leukemia (AML) or a bone marrow condition called MDS that still shows signs of disease after prior treatment. The therapy uses specially engineered immune cells designed to attack leukemia cells that carry a marker called CD33. **You may be eligible if...** - You are 18 or older - You have AML or MDS that has relapsed or did not respond to prior treatments including chemotherapy or targeted agents like venetoclax - Your cancer tests positive for the CD33 marker - Your organ function is adequate - Your disease shows measurable residual disease (MRD) — meaning small amounts of cancer remain in your bone marrow **You may NOT be eligible if...** - You have untreated or active brain involvement by leukemia - You have serious heart, liver, or lung problems - You are pregnant or breastfeeding - You have an active serious infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCD33 FPBMC

Participants will receive up to 4 cycles of 4 weekly infusions of CD33 infusions followed by 4-6 weeks of a hypomethylating agent with or without venetoclax according to standard clinical care.

Locations(1)

University of Virginia

Charlottesville, Virginia, United States

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NCT07270978

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