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Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

StatusRecruiting
PhasePhase 2
Started2026-10-15
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
minor
Study Status, Eligibility, Contacts/Locations v10
Start date2026-09-01→2026-10-15
Eligibility criteria+215 characters
[...] by local health authority Absolute neutrophil count (ANC) ≥750/μL (or ≥500/µLμL in participants with documented bone marrow involvement) Growth factor and/or transfusion support is permissible to stabilize participant prior to study treatment if needed No lower limit if cytopenia is related to bone marrow involvement Hemoglobin ≥ 8 g/dL Growth factor and/or transfusion support [...] to stabilize participant prior to study treatment if needed NoPlatelets lower≥50 limit000/μL if(or cytopenia≥30 is000/μL relatedin toparticipants with documented bone marrow involvement) Platelets ≥ 25 000/µL Growth fact [...] [...]
Study sitescontacts updated at 1 of 1 site
2026-08-10
minor
Study Status v9
Start date2026-08-01→2026-09-01
2026-07-09
minor
Study Status v8
Start date2026-07-01→2026-08-01
2026-06-04
minor
Study Status v7
Start date2026-05-29→2026-07-01
2026-05-15
minor
Study Status v6
Re-verified, no change to tracked fields
2026-04-29
notable
Study Status, Contacts/Locations v5
Recruitment opened
Start date2026-07-01→2026-05-29
Study sitesdetails revised at 1 of 1 site
2026-04-15
minor
Study Status v4
Re-verified, no change to tracked fields
2026-04-06
minor
Study Status v3
Start date2026-04-01→2026-07-01
2026-01-07
minor
Study Status v2
Start date2025-12→2026-04-01
2025-11-03
minor
Study Status v1
Start date2025-10→2025-12
2025-09-19
minor
Original filing
This phase II trial studies how well the addition of nemtabrutinib to lisocabtagene maraleucel in treating patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Nemtabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lisocabtagene maraleucel is a type of treatment called chimeric antigen receptor (CAR) T-cell therapy, in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T-cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion for treatment. Adding nemtabrutinib to lisocabtagene maraleucel may be an effective treatment for relapsed/refractory CLL/SLL.
Trial Details
NCT Number NCT07194980
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: Merck Sharp & Dohme LLC
Conditions Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Enrollment 20 participants
Start Date 2026-10-15
Primary Completion 2029-10-20 (estimated)
Study Completion 2029-10-20 (estimated)
Updated on ClinicalTrials.gov 2026-09-11