DC vaccine CD-FDC-001

ClinicalTrials.gov: DC VACCINATION FOR POST-REMISSION THERAPY IN AML 

March 2015, Medigene started a clinical open-label Phase I/II trial with its DC vaccine for the treatment of acute myeloid leukemia (AML) at Oslo University Hospital and published final topline data in January 2020.

Status

 terminated

Study

Phase I/II

6 patients in Phase I and after positive  Data and Safety Monitoring Boards (DSMB) recommendation continued with 14 patients  in Phase II

Enrollment

A total of 20 subjects (median age 59, range 24 to 73) with AML (risk groups good, intermediate, poor: 13, 5, 2), in morphologic complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) after induction or consolidation therapy, not eligible for allogeneic hematopoietic stem cell transplantatio

Primary endpoint

safety and feasibility

Secondary endpoint

overall survival, progression-/relapse free survival, time to progression, control of minimal residual disease and induction of immune responses

Indication

Acute myeloid leukemia (AML)

Resultssee press release

 

Further studies utilizing Medigene’s DC vaccine technology include two clinical investigator-initiated trials: a clinical Phase I/II trial in AML at the Ludwig-Maximilians-University Hospital of Munich Großhadern and a clinical Phase II trial in prostate cancer at Oslo University Hospital. Moreover, a compassionate use program is being conducted at the Department of Cellular Therapy at Oslo University Hospital.