Actively Recruiting
Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Led by Fred Hutchinson Cancer Center · Updated on 2026-05-01
20
Participants Needed
1
Research Sites
177 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of CLL/SLL per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) classification
- Measurable disease by imaging (lymph node > 1.5cm) or absolute lymphocyte count (> 5000/μL) or marrow involvement of at least 30% by flow cytometry
- Eligible for lisocabtagene maraleucel as standard-of-care per FDA label for CLL/SLL
- At least 18 years of age at time of study enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Ability to swallow and retain oral medication (nemtabrutinib not permitted through J PEG tube)
- Hepatitis B surface antigen positive participants eligible if on antiviral therapy at least 4 weeks with undetectable viral load
- Absolute neutrophil count ≥ 500/μL (growth factor/transfusion support allowed if needed)
- Hemoglobin ≥ 8 g/dL (growth factor/transfusion support allowed if needed)
- Platelets ≥ 25,000/μL (growth factor/transfusion support allowed if needed)
- Creatinine ≤ 1.5× upper limit of normal (ULN) or creatinine clearance ≥ 30 mL/min
- Total bilirubin ≤ 1.5× ULN or direct bilirubin ≤ ULN
- AST and ALT ≤ 2.5× ULN (≤ 5× ULN if liver metastases present)
- INR or prothrombin time ≤ 1.5× ULN unless on anticoagulants within therapeutic range
- Activated partial thromboplastin time ≤ 1.5× ULN unless on anticoagulants within therapeutic range
- Cardiac ejection fraction ≥ 40% by echocardiogram or MUGA scan
You will not qualify if you...
- Diagnosis of Richter Transformation
- Symptomatic central nervous system involvement at enrollment (previously treated CNS disease allowed if asymptomatic)
- Active and uncontrolled infection
- Active hepatitis B or hepatitis C infection (must have completed antiviral therapy for HCV at least 4 weeks prior)
- HIV with detectable viral load or CD4 count ≤ 350 cells/μL at screening or recent AIDS-defining infection
- Gastrointestinal dysfunction affecting drug absorption (e.g., gastric bypass, gastrectomy)
- Significant conditions or abnormalities interfering with study participation or results
- Corrected QT interval prolongation (> 450 msecs) or significant ECG abnormalities
- Known allergy or sensitivity to nemtabrutinib or excipients
- Prior progressive disease while on nemtabrutinib
- Severe bleeding disorder
- History of second malignancy (except certain skin cancers and carcinoma in situ)
- Positive pregnancy test within 72 hours prior to enrollment for participants of childbearing potential
- Need for additional bridging therapy beyond allowed exceptions
- Current treatment with P-gp substrates with narrow therapeutic index, CYP3A strong inducers or inhibitors without proper washout
- Live vaccine within 30 days before first dose
- Enrollment in another therapeutic clinical trial impacting cancer therapy efficacy
- Recent investigational agent or device use within 4 weeks
- Not recovered from major surgery or ongoing surgical complications
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Any condition deemed not in participant's best interest by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
F
Fred Hutch Immunotherapy Intake
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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