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Phase Ib Study of CD33 FPBMC in Patients With MRD+ AML or MDS | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT07270978•University of Virginia

View on ClinicalTrials.gov

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.

Detailed Description

Once subjects are determined to be eligible, white blood cells (lymphocytes) are collected via leukapheresis procedure. The T cells in the mononuclear cells are coated with bispecific antibody to activate the T cells and the mononuclear cells are reinfused into the patients so the T cells can multiply and kill AML/MDS cells. At least 72 hours after the leukapheresis procedure, study treatment will start. 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. After about 2 cycles of study treatment, participants will have another leukapheresis procedure. Before, throughout and following study treatment, research blood will be collected to better understand immune response. Disease status will be checked regularly during and after study treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Adults: ≥18 years of age 2. Diagnosis of either:
•1. Newly diagnosed or relapsed/refractory AML who have received either intensive induction chemotherapy or at least 2 cycles of a non-intensive options such as hypomethylating agent and venetoclax or other targeted agent
•2. Relapsed/ refractory (R/R) MDS who have received at least 2 prior cycles of hypomethylating agent and venetoclax or single agent hypomethylating agent for at least 4 cycles
•3. Relapsed/refractory (R/R) MDS/MPN overlap syndromes like CMML who have received at least 2 prior cycles of azacitidine and venetoclax or single agent hypomethylating agent for at least 4 cycles 3. For patients with targetable mutations (IDH1, IDH2, KMT2A, or FLT3): Receipt of and/or decision not to receive associated inhibitor.
•4\. Patients with R/R MDS or R/R MDS/MPN overlap syndromes must have at least one of the following:
•1. Bone marrow blasts ≥ 5%
•2. Appearance of previously absent leukemic blasts in peripheral blood
•3. Absolute neutrophil count \<1 x 109/L and 50% below best unsupported on-study value
•4. Platelet count \<100 x 109/L and 50% below best unsupported on-study value
•5. Hemoglobin \<11g/dL, and ≥2 g/dL reduction from best unsupported on-study value
+7 more criteria

Exclusion Criteria

•1. Pregnancy or lactation
•2. Prior treatment with anti-CD33 therapy
•3. Patients who are being actively considered for stem cell transplant, unless participation in the study prior to the planned stem cell transplant is considered to be in the best interest of the patient in the opinion of the treating investigator in consultation with the transplant team. This does not exclude patients that may be eligible for stem cell transplant at some future (undetermined) date.
•4. Past hematopoietic stem cell transplant (HSCT) with graft vs host disease requiring systemic immunosuppression other than low dose prednisone (10 mg) (or the equivalent dose of another immunosuppressant) within the 4 weeks before registration
•5. Clinically significant organ dysfunction, defined as any of the following:
•* 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).
+7 more criteria

Locations (1)

University of Virginia

Charlottesville, Virginia, United States

Key Dates

Start Date

February 1, 2026

Primary Completion Date

July 1, 2028

Completion Date

June 1, 2031

Last Updated

March 13, 2026

Enrollment

ESTIMATED participants

Conditions

Acute Myeloid LeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasm

Interventions

CD33 FPBMC

DRUG

Contacts

Ashley Donihee

CONTACT

434-243-6377 zwz6jm@uvahealth.org

Avani Hopkins

CONTACT

434-243-8108 AJH7JQE@uvahealth.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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