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DEC-205/NY-ESO-1 Fusion Protein CDX-1401 · 1 trial · 6 indications
Will evaluate the proportion of n=8 evaluable patients in the expansion cohort experiencing a dose-limiting toxicity. Toxicity rates will be described using upper 1-sided 95% Jeffreys binomial confidence intervals.
| Arm | Type | Description |
|---|---|---|
| Treatment (CDX-1401, poly ICLC, decitabine, nivolumab) | EXPERIMENTAL | Patients receive 1mg/1.8mg DEC-205/NY-ESO-1 fusion protein CDX-1401 intracutaneously and poly ICLC SC on day -14, on day 15 of courses 1-4, and then on day 1 of every 4 courses thereafter. Patients also receive 3mg/kg nivolumab IV over 30 minutes on days 1 and 15 and 20 mg/m2 decitabine IV over 1 hour on days 1-5. Courses with nivolumab and decitabine repeat every 4 weeks in the absence of disease progression or unaccepted toxicity. |
| Name | Type | Description |
|---|---|---|
| DEC-205/NY-ESO-1 Fusion Protein CDX-1401 | BIOLOGICAL | Given intracutaneously |
| Decitabine | DRUG | Given IV |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Nivolumab | BIOLOGICAL | Given IV |
| Poly ICLC | DRUG | Given SC |
Inclusion Criteria: * Have a confirmed diagnosis of: * International Prognostic Scoring System (IPSS) intermediate-1, intermediate-2 or high-risk MDS including chronic myelomonocytic leukemia (CMML) OR * Low blast count AML with =\< 30% blasts previously classified as refractory anemia with ex...
DEC-205/NY-ESO-1 Fusion Protein CDX-1401 is an investigational monoclonal antibody being studied for the treatment of Acute Myeloid Leukemia. It is also being evaluated in related conditions such as Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia. The drug is in Phase 1 clinical development and has not been approved by the FDA.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401 targets the DEC-205 receptor and the NY-ESO-1 tumor antigen. The fusion protein is designed to deliver NY-ESO-1 to DEC-205-expressing dendritic cells, which may stimulate an immune response against cancer cells expressing NY-ESO-1.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401 is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CLDX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Acute Myeloid Leukemia and related blood cancers.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA for any use. The Phase 1 trial has been completed, and the drug remains under investigation for Acute Myeloid Leukemia and other hematologic malignancies.
DEC-205/NY-ESO-1 Fusion Protein CDX-1401 has been studied in one completed Phase 1 clinical trial, registered as NCT03358719. The trial evaluated the drug in combination with Poly ICLC, Decitabine, and Nivolumab in patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia. The study enrolled 8 participants in the United States.
Yes, DEC-205/NY-ESO-1 Fusion Protein CDX-1401 is also known as CDX-1401. The drug is a fusion protein that combines the DEC-205 antibody with the NY-ESO-1 tumor antigen, and it is being developed by Celldex Therapeutics for the treatment of Acute Myeloid Leukemia and other cancers.