Curis sets up TakeAim CLL dosing by July, data due December 2026
The Phase 2 combination trial pairs emavusertib with zanubrutinib in patients whose CLL persists despite the BTK inhibitor, testing whether adding an IRAK4/FLT3 blocker can deepen response.
Executive Summary
- Curis confirmed its CLL combination trial has reached site-activation milestones and reaffirmed the timing for dosing its first patients, keeping the study on its stated operational track.
- The trial tests whether adding an IRAK4 and FLT3 inhibitor to an already-approved BTK inhibitor can deepen responses in patients whose disease persists or progresses on BTK inhibition alone.
- No other industry trial pairs this mechanism with a BTK inhibitor in this exact resistance population, leaving the combination without a direct comparator in the current competitive field.
- The company has pointed to initial data by the end of this year, which will be the first readable signal on whether the combination changes response depth in a group that has exhausted a leading standard therapy.
The update
Curis, Inc. said on June 26, 2026 that eleven clinical sites had been initiated and opened for enrollment in the TakeAim CLL study (CA-4948-203, NCT07271667), an open-label Phase 2 trial combining its oral IRAK4 and FLT3 inhibitor emavusertib with the BTK inhibitor zanubrutinib in chronic lymphocytic leukemia. The company reaffirmed that it expects to dose the initial five patients by the end of July 2026, with data expected in December 2026. James Dentzer, the company's President and CEO, said Curis was "pleased with both our operational progress in the CLL study and the support from our shareholders". CurisCuris Announces Eleven Active Clinical Sites in TakeAim CLL Study, Reaffirms Patient Dosing Guidance, and Reports Stockholder Approval of Reverse Stock SplitJun 26, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial tests
The study enrolls two cohorts. Cohort 1 covers patients on zanubrutinib for at least 12 months who have reached only a partial response, or a partial response with lymphocytosis, and remain measurable-residual-disease-positive by the ClonoSEQ assay; its primary endpoint is the undetectable measurable residual disease (uMRD) rate. Cohort 2 enrolls patients who progressed on zanubrutinib within the prior three months; its primary endpoint is overall response rate. The trial targets 108 adult participants across the United States, Italy, and Spain, and carries a registered primary completion date of November 1, 2027. NCT07271667A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell MalignanciesNCT07271667
Operational status
The trial moved to Recruiting status on February 13, 2026, after starting as Not yet recruiting, and its enrollment target has held at 108 since the registry record was created, with no protocol amendments to endpoints, eligibility, or primary completion date recorded. That combination, an unchanged enrollment target and a single status-only amendment, reads as ordinary trial startup rather than a program under stress. NCT07271667A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell MalignanciesNCT07271667
Competitive position
No other industry-sponsored trial pairs an IRAK4 and FLT3 inhibitor with a BTK inhibitor in chronic lymphocytic leukemia; the closest comparators in this indication, including BeOne Medicines' sonrotoclax and Merck's nemtabrutinib, target BCL2 and BTK respectively, not the IRAK4/FLT3 axis emavusertib blocks. The nearest mechanism precedent is emavusertib's own earlier-stage program in primary central nervous system lymphoma, and AstraZeneca's AZD2962, an IRAK4 inhibitor in earlier-phase testing for blood cancers broadly. With no validated combination strategy established for deepening response after BTK-inhibitor resistance in this setting, a uMRD or response-rate signal that clears the trial's own thresholds in either cohort would be the result that distinguishes this approach.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.