CA-4948-103 is a Phase 1, single-arm, open-label study evaluating CA-4948 (emavusertib) in combination with Azacitidine and Venetoclax in patients with Acute Myeloid Leukemia (AML). The primary objective is to evaluate the safety and tolerability of this triplet regimen and to identify dose-limiting toxicities. Eligible participants are adults in complete remission (CR/CRi) who remain positive for measurable residual disease (MRD+). MRD status is confirmed during screening using flow cytometry or molecular assessment. All participants receive the investigational combination therapy to assess clinical safety and tolerability. Key secondary endpoints include the conversion of MRD status from positive to negative and the pharmacokinetic profiles of the study drugs.
This clinical trial is a Phase 1 study evaluating the new drug CA-4948 in combination with Azacitidine and Venetoclax. The study focuses on patients with Acute Myeloid Leukemia (AML) who are in complete remission but still have a small number of detectable cancer cells left in their body. The primary goal is to assess the safety and tolerability of this specific drug combination. Participants are adults who are at risk of a relapse due to these remaining cancer cells despite a successful initial response to therapy. Patients will receive the medication according to a structured plan while their health and blood counts are closely monitored. This research aims to determine if adding CA-4948 can effectively help to further reduce the presence of residual cancer cells.
