drugset / Trial / NCT02992860

Single Agent JNJ-56022473 in MDS and AML Patients FAILING HYPOMETHYLATING AGENT BASED THERAPY

NCT02992860

Phase 2 Terminated 25 enrolled GWT-TUD GmbH
NaSingle-groupOpen-labelTreatment

Summary

The outcome of HMA-refractory patients with MDS or AML is dismal with a median survival of 5 months after failure, representing a significant unmet medical need due to the very limited treatment options. In this context, a specific targeting of the leukemic stem cell (LSC) seems a promising option to selectively combat the leukemic progenitor cells. In fact, CD123 is overexpressed in AML and MDS progenitors making it an attractive target for immunotherapy-based approaches. JNJ-56022473 is a promising compound that has been engineered with regard to this strategy and the current phase II trial has the aim to evaluate the overall hematological response rate at 3 months in HMA refractory/relapsed AML and MDS patients.

Timeline

Start
2016-07
Primary completion
2018-10
Completion
2018-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Talacotuzumab Monoclonal antibody 9 mg/kg Intravenous