LEXINGTON, Mass., July 6, 2026
Curis, Inc. announced an important enrollment milestone for its Phase 2 TakeAim CLL clinical trial, with the first six patients now consented to participate in the study evaluating emavusertib (CA-4948) in combination with zanubrutinib for the treatment of chronic lymphocytic leukemia (CLL). The company reaffirmed its guidance to dose the first five patients by the end of July 2026 and expects to report initial clinical data from the study in December 2026.
Study Evaluates Dual NF-kB Pathway Blockade to Improve Treatment Responses
The TakeAim CLL study is investigating whether combining emavusertib, an orally available small-molecule IRAK4 and FLT3 inhibitor, with the BTK inhibitor zanubrutinib can deliver deeper clinical responses by simultaneously blocking both the Toll-like receptor (TLR) and B-cell receptor (BCR) signaling pathways that drive NF-kB dysregulation, a key mechanism underlying chronic lymphocytic leukemia. While BTK inhibitors remain the current standard of care and have demonstrated high objective response rates, complete responses remain relatively uncommon. By targeting both signaling pathways, researchers aim to improve response depth and increase the likelihood of achieving complete remission and undetectable measurable residual disease (MRD).
Phase 2 Trial Focuses on Patients with Residual Disease After BTK Inhibitor Therapy
The open-label Phase 2 TakeAim CLL study (CA-4948-203; NCT07271667) is enrolling patients with chronic lymphocytic leukemia who remain in partial response (PR) or partial response with lymphocytosis (PR-L) despite receiving at least 12 months of zanubrutinib therapy. Eligible participants must also have MRD-positive disease confirmed using the clonoSEQ assay. According to Curis, strong interest from participating clinical sites and key opinion leaders has enabled enrollment to progress ahead of expectations following the activation of eleven study sites in June 2026.
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Emavusertib Continues Broad Clinical Development Across Hematologic Malignancies
Emavusertib is being developed as a novel oral inhibitor of IRAK4 and FLT3 across multiple hematologic cancers. In addition to the TakeAim CLL program, Curis is evaluating the investigational therapy in the TakeAim Lymphoma Phase 1/2 trial, where it is being combined with ibrutinib for patients with relapsed or refractory primary central nervous system lymphoma (PCNSL). The company has also substantially completed its clinical studies in acute myeloid leukemia (AML) and plans to continue development in AML as additional funding becomes available. Emavusertib has received U.S. FDA Orphan Drug Designation for the treatment of PCNSL, AML, and myelodysplastic syndromes (MDS), as well as European Commission Orphan Drug Designation for PCNSL, supporting its continued advancement across multiple blood cancers.
Source: Curis press release
