Trial intelligence / Profile preview

Nemtabrutinib in Refractory CLL/SLL

NCT07796373Phase 2

Key facts

Status: Not yet recruiting
Start: Nov 2026
Primary completion: Dec 2030
Countries: 1
Sponsor: National Heart, Lung, and Blood Institute

Drugs: nemtabrutinib
Conditions: chronic lymphocytic leukemia (CLL)chronic lymphocytic leukemia (SLL/CLL)

Overview

Phase 2, open-label, single-arm trial of nemtabrutinib in chronic lymphocytic leukemia (CLL) and chronic lymphocytic leukemia (SLL/CLL), sponsored by National Heart, Lung, and Blood Institute. Primary endpoint: Overall Response Rate. Planned start Nov 2026; status: not yet recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Treatment
Nemtabrutinib 65 mg orally once daily in 28-day cycles.

Who it enrols

Adults with CLL or SLL refractory to a covalent BTK inhibitor or pirtobrutinib, and previously treated with a BCL2 inhibitor, with measurable disease and adequate organ function.

Endpoints

Primary

Overall Response RateAfter 6 cycles

Secondary

Progression-Free SurvivalUp to disease progression or death
Time to ResponseUp to partial remission or better
Overall Response Rate, Progression-Free Survival, and Time to Response in BTK and PLCG2 wild-type and mutated CLLAfter 6 cycles with ongoing assessments
Overall Response Rate, Progression-Free Survival, and Time to Response based on IGHV mutational status and cytogenetic abnormalitiesAfter 6 cycles with ongoing assessments

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