Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor

ClinicalTrials.gov ID: NCT07796373

Public ClinicalTrials.gov record NCT07796373. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Study Description: This is a phase 2 study of nemtabrutinib for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) refractory to treatment with covalent Bruton tyrosine kinase inhibitor (BTKi) or pirtobrutinib, and previously treated with B-cell lymphoma 2 inhibitor (BCL2i). Subjects will be treated with nemtabrutinib 65 mg by mouth once daily until disease progression or toxicity. Efficacy will be evaluated separately in CLL/SLL refractory to covalent BTKi (cBTKi) and in CLL/SLL refractory to pirtobrutinib. Efficacy will also be evaluated in molecular subgroups based on BTK and PLCG2 mutations, IGHV mutational status, and cytogenetic abnormalities. The pharmacodynamic effects of nemtabrutinib on tumor and immune cells will be assessed in peripheral blood, lymph node, and bone marrow. Clonal shifts during treatment with nemtabrutinib will be described. For the purposes of this protocol, the term CLL will be used throughout to refer collectively to chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), unless otherwise specified. Objectives: Primary Objectives: * Evaluate the efficacy of nemtabrutinib in CLL refractory to cBTKi and previously treated with BCL2i * Evaluate the efficacy of nemtabrutinib in CLL refractory to pirtobrutinib and previously treated with BCL2i Secondary Objectives: * Evaluate the efficacy of nemtabrutinib in CLL with and without BTK and PLCG2 mutations * Evaluate the efficacy of nemtabrutinib in CLL prognostic risk groups Exploratory Objectives: * Characterize the pharmacodynamic effects of nemtabrutinib on tumor and immune cells * Understand clonal shifts during treatment with nemtabrutinib * Identify potential biomarkers predictive of response to nemtabrutinib Endpoints: Primary Endpoints: * Overall response rate (ORR) to nemtabrutinib in CLL refractory to cBTKi and previously treated with BCL2i * ORR to nemtabrutinib in CLL refractory to pirtobrutinib and previously treated with BCL2i Secondary Endpoints: * Progression-free survival (PFS) and time to response (TTR) during treatment with nemtabrutinib in CLL refractory to cBTKi and previously treated with BCL2i * PFS and TTR during treatment with nemtabrutinib in CLL refractory to pirtobrutinib and previously treated with BCL2i * ORR, PFS, and TTR in BTK and PLCG2 wild-type and mutated CLL * ORR, PFS, and TTR based on IGHV mutational status and cytogenetic abnormalities Exploratory Endpoints: * Gene expression profiling in tumor and immune cells from peripheral blood, lymph node, and bone marrow during treatment with nemtabrutinib * Targeted or whole genome/exome sequencing of tumor cells during treatment with nemtabrutinib * Association between ORR, PFS, and potential biomarkers (e.g., molecular, serum) * Overall survival (OS) during treatment with nemtabrutinib in CLL refractory to cBTKi and previously treated with BCL2i * OS during treatment with nemtabrutinib in CLL refractory to pirtobrutinib and previously treated with BCL2i

Study identification

NCT ID: NCT07796373
Recruitment status: Not yet recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI); NIH
Enrollment: 32 participants

Conditions and interventions

Conditions

Interventions

Nemtabrutinib Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 100 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 5, 2026
Primary completion: Nov 30, 2030
Completion: Nov 30, 2031
Last update posted: Aug 31, 2026

2026 – 2031

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
National Institutes of Health Clinical Center	Bethesda	Maryland	20892	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07796373, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 31, 2026 · Synced Sep 1, 2026

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The complete protocol, eligibility criteria, and contact information for NCT07796373 live on ClinicalTrials.gov.

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