This phase II trial tests whether camidanlumab tesirine works in treating patients with acute myeloid leukemia, myelodysplastic syndrome, or myeloproliferative neoplasms that have come back (relapsed) or do not respond to treatment (refractory). Camidanlumab tesirine is a monoclonal antibody, called camidanlumab, linked to a chemotherapy drug, called tesirine. Camidanlumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD25 receptors, and delivers tesirine to kill them.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04639024.
PRIMARY OBJECTIVES:
I. Assess the morphologic complete response rate of camidanlumab tesirine (ADCT-301) given to patients who have relapsed/persistent acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS/myeloproliferative neoplasm (MPN) following allogeneic transplantation.
II. Assess the safety of ADCT-301 given to patients who have relapsed/persistent AML , MDS, or MDS/MPN following allogeneic transplantation.
EXPLORATORY SECONDARY OBJECTIVES:
I. Assess the molecular complete remission rate of study patients.
II. Assess duration of response in responding patients.
III. Assess impact on CD25 T cell subset and thus occurrence of graft versus host disease (GVHD).
IV. Assess impact of infusions on measures of immune reconstitution.
OUTLINE:
Patients receive camidanlumab tesirine intravenously (IV) over 30-60 minutes on days 1, 8, and 15 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who are tolerating camidanlumab tesirine, may receive up to 6 cycles.
After completion of study treatment, patients are followed up every 12 weeks for up to 12 months after the first dose of study drug.
Lead OrganizationDuke University Medical Center
Principal InvestigatorGwynn Douglas Long
