A Phase 1 Study of DEC205mAb-NY-ESO-1 Fusion Protein (CDX-1401) Given With Adjuvant PolyICLC in Conjunction With 5-Aza-2'Deoxycytidine (Decitabine) in Patients With MDS or Low Blast Count AML
I. Evaluate the safety of Anti-DEC-205-NY-ESOI (CDX-1401) fusion protein (DEC-205/NY-ESO-1
fusion protein CDX-1401) given in combination with decitabine 20 mg/m^2 intravenously.
I. To evaluate NY-ESO-1 specific cellular and humoral immunity by determination of NY-ESO-1
specific antibody, and T-cell clones following standard treatment with
5-aza-2'-deoxycytidine (decitabine) in conjunction with immune sensitization with Anti-DEC
205-NY-ESO-I fusion protein (CDX-1401).
II. To determine the impact of decitabine treatment on peripheral blood cells from patients
treated in this manner on NY-ESO-1 target gene expression, NY-ESO protein expression,
NY-ESO-1 promoter methylation, and global deoxyribonucleic acid (DNA) methylation.
I. To record the response rate (complete response, partial response and hematological
improvement) in myelodysplastic syndrome (MDS) or low blast count acute myeloid leukemia
(AML) patients treated with the combination in order to provide descriptive characteristics.
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 subcutaneously (SC) and
intradermally (ID) and poly-ICLC subcutaneously (SC) on day -14 and day 15 of courses 1-4.
Patients also receive decitabine intravenously (IV) over 1 hour on days 1-5. Treatment
repeats every 28 days for up to 4 courses in the absence of disease progression or
After completion of study treatment, patients are followed up at 30, 60, 90, and 180 days.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Grade 3+ adverse event and serious adverse event (SAE) rate, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
Toxicity rates will be described using upper one-sided 95% Clopper Pearson binomial confidence intervals.
Up to 30 days after last dose of study treatment
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|