Actively Recruiting
Phase Ib Study of CD33 FPBMC in Patients With MRD+ AML or MDS
Led by University of Virginia · Updated on 2026-05-11
23
Participants Needed
1
Research Sites
274 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase Ib Study of CD33 FPBMC in Patients With MRD+ AML or MDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Diagnosed with newly diagnosed or relapsed/refractory AML after intensive chemotherapy or at least 2 cycles of non-intensive therapy
- Diagnosed with relapsed/refractory MDS after at least 2 prior cycles of hypomethylating agent with or without venetoclax, or single agent hypomethylating agent for at least 4 cycles
- Diagnosed with relapsed/refractory MDS/MPN overlap syndromes like CMML after at least 2 prior cycles of azacitidine with venetoclax or single agent hypomethylating agent for at least 4 cycles
- For patients with targetable mutations (IDH1, IDH2, KMT2A, or FLT3), must have received or decided not to receive associated inhibitors
- Patients with relapsed/refractory MDS or MDS/MPN must have at least one of the following: bone marrow blasts ≥ 5%, new leukemic blasts in blood, neutrophil count <1 x 10^9/L and 50% below best on-study value, platelet count <100 x 10^9/L and 50% below best on-study value, hemoglobin <11g/dL with ≥2 g/dL drop from best on-study value, or increased transfusions by over 30% in 8 weeks
- Patients with AML must have persistent or recurrent MRD positivity defined by blasts ≥5% and/or disease detected by flow cytometry at ≥0.1%, and/or persistent genomic mutations or cytogenetic abnormalities
- Residual blasts must express CD33 at any level
- Left Ventricular Ejection Fraction (LVEF) ≥ 45% at rest
- Performance status ≤ 2 on ECOG scale
- Females of childbearing potential and males must use effective contraception during treatment and for 90 days after
- Ability to provide written informed consent
- For dose expansion, must meet criteria for relapsed/refractory MDS or AML population
You will not qualify if you...
- Pregnancy or breastfeeding
- Prior treatment with anti-CD33 therapy
- Currently being actively considered for stem cell transplant unless study participation prior to transplant is deemed in patient's best interest
- Past hematopoietic stem cell transplant with graft vs host disease requiring systemic immunosuppression (other than low dose prednisone) within 4 weeks before registration
- Clinically significant organ dysfunction including elevated liver enzymes (AST or ALT >3x ULN), bilirubin >1.5x ULN unless due to hemolysis or Gilbert's syndrome, low absolute lymphocyte count (<300/microliter), low creatinine clearance (<30 mL/min), or active serious infection not controlled by antibiotics
- Known HIV infection with detectable viral load
- Known hepatitis B surface antigen positive or active hepatitis C infection unless viral load is undetectable
- Prior or concurrent malignancy that may interfere with safety or efficacy assessment
- Treatment with antileukemic agents or chemotherapy (other than hypomethylating agents or venetoclax) within 7 days or 5 half-lives before study entry
- Known allergy to hypomethylating agents
- Blasts ≥ 25%
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
A
Ashley Donihee
CONTACT
A
Avani Hopkins
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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