Back to search results

Phase Ib Study of CD33 FPBMC for AML or MDS

This study is testing a treatment called CD33 FPBMC for people with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) who still have signs of disease (MRD+) after previous treatments. CD33 FPBMC involves using your own white blood cells (lymphocytes) that are specially prepared to target and kill AML/MDS cells. You would receive four weekly infusions of CD33 FPBMC, followed by 4-6 weeks of standard treatment with a hypomethylating agent (a type of chemotherapy like decitabine or azacitidine) and possibly venetoclax. This cycle may be repeated up to four times. The main goal is to see how safe CD33 FPBMC is and to get an early idea of how well it works. This study is for adults aged 18 and older who meet specific criteria regarding their AML or MDS diagnosis and prior treatments. The study plans to enroll 23 participants.

Study design
This is an interventional study, meaning participants receive a specific treatment. It plans to enroll 23 participants.
What's involved
You would undergo a procedure to collect your white blood cells (leukapheresis). Then, you would receive 4 weekly infusions of CD33 FPBMC, followed by 4-6 weeks of standard treatment. This cycle may repeat up to 4 times, with another leukapheresis after about 2 cycles. Blood samples will be collected regularly.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored from the start of treatment through 7 days after the 4th infusion. Disease status will be checked regularly during and after study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07270978

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Virginia
~23 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:CD33 FPBMC

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
DLTs
Measured over From start of treatment through 7 days after the 4th infusion (for each participant)

Conditions

Acute Myeloid Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasm

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic/Myeloproliferative NeoplasmMyelodysplastic SyndromeIDH1 GeneIDH2 GeneKMT2A GeneReceptor-Type Tyrosine-Protein Kinase FLT3

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Daniel Reed, MD · PRINCIPAL_INVESTIGATOR · Assistant Professor
  • Lawrence Lum, MD, DSc · STUDY_DIRECTOR · IND Sponsor

Who to contact

Ashley Donihee
[email protected]
434-243-6377
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Exclusion

AST or ALT \>3x the upper limit of normal (ULN)
Total bilirubin \>1.5x the ULN, unless due to ongoing hemolysis or Gilbert's syndrome, in which case \> 3.0 mg/dL
Absolute lymphocyte count (ALC) \< 300 lymphocytes/microliter
Creatinine clearance \<30 mL/min
Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of clinical improvement despite antimicrobial treatment). 6. Known human immunodeficiency virus (HIV) with detectable viral load. 7. Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection

What this trial measures

  • DLTsFrom start of treatment through 7 days after the 4th infusion (for each participant)

    Escalation phase participants only