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

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. Th

Trial Details

NCT ID
NCT07270978
Phase
PHASE1
Sponsor
University of Virginia
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • CD33 FPBMC
Locations (sample)
  • Charlottesville, Virginia, United States|38.02931,-78.47668

Key Eligibility Criteria

  • 1\. Adults: ≥18 years of age 2. Diagnosis of either:
  • Newly diagnosed or relapsed/refractory AML who have received either intensive induction chemotherapy or at least 2 cycles of a non-intensive option…
  • Relapsed/ refractory (R/R) MDS who have received at least 2 prior cycles of hypomethylating agent and venetoclax or single agent hypomethylating ag…
  • Relapsed/refractory (R/R) MDS/MPN overlap syndromes like CMML who have received at least 2 prior cycles of azacitidine and venetoclax or single age…

For full eligibility, visit ClinicalTrials.gov.

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