OncoMatch/Clinical Trials/NCT07270978
Phase Ib Study of CD33 FPBMC in Patients With MRD+ AML or MDS
Is NCT07270978 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CD33 FPBMC for acute myeloid leukemia.
Treatment: CD33 FPBMC — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Biomarker criteria
Required: CD33 expression at any level (any)
Residual blasts must be positive for CD33 expression at any level. Note: Patients whose most recent disease-positive evaluation by flow cytometry showed CD33 expression but whose current assessment for MRD is only positive for genomics or cytogenetics may be included.
Allowed: IDH1 targetable mutation
For patients with targetable mutations (IDH1, IDH2, KMT2A, or FLT3): Receipt of and/or decision not to receive associated inhibitor.
Allowed: IDH2 targetable mutation
For patients with targetable mutations (IDH1, IDH2, KMT2A, or FLT3): Receipt of and/or decision not to receive associated inhibitor.
Allowed: KMT2A (MLL) targetable mutation
For patients with targetable mutations (IDH1, IDH2, KMT2A, or FLT3): Receipt of and/or decision not to receive associated inhibitor.
Allowed: FLT3 targetable mutation
For patients with targetable mutations (IDH1, IDH2, KMT2A, or FLT3): Receipt of and/or decision not to receive associated inhibitor.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: intensive induction chemotherapy — AML
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
Must have received: hypomethylating agent and venetoclax — AML
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
Must have received: hypomethylating agent and venetoclax — MDS
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
Must have received: hypomethylating agent — MDS
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
Must have received: azacitidine and venetoclax (azacitidine, venetoclax) — MDS/MPN
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
Must have received: hypomethylating agent — MDS/MPN
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
Cannot have received: anti-CD33 therapy
Prior treatment with anti-CD33 therapy
Lab requirements
Blood counts
Absolute lymphocyte count (ALC) < 300 lymphocytes/microliter
Kidney function
Creatinine clearance <30 mL/min
Liver function
AST or ALT >3x ULN; Total bilirubin >1.5x ULN unless due to ongoing hemolysis or Gilbert's syndrome, in which case >3.0 mg/dL
Cardiac function
Left Ventricular Ejection Fraction (LVEF) ≥ 45% at rest (MUGA or echocardiogram)
Clinically significant organ dysfunction, defined as any of the following: AST or ALT >3x ULN; Total bilirubin >1.5x 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; LVEF ≥ 45% at rest (MUGA or echocardiogram)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Virginia · Charlottesville, Virginia
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