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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT07270978
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CD33 FPBMC — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 26, 2026
Status verified
May 2026
Primary completion
Aug 31, 2028
Completion
Jul 31, 2031

Study Design

Enrollment
23 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CD33 FPBMC + hypomethylating agent with or without venetoclax
    4 weekly infusions of CD33 fresh peripheral blood mononuclear cells (FPBMC) followed by 4-6 weeks of hypomethylating agent with/without venetoclax.

Primary Outcome Measure

DLTs [ Time Frame: From start of treatment through 7 days after the 4th infusion (for each participant) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22908
Ashley Donihee
[email protected]
434-243-6377
Avani Hopkins
[email protected]
434-243-8108
Daniel Reed, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Virginia· Charlottesville, VA

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