Nemtabrutinib and Lisocabtagene Maraleucel for Relapsed/Refractory CLL/SLL
This study is testing if adding nemtabrutinib to lisocabtagene maraleucel (a CAR T-cell therapy) helps treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has returned or isn't responding to other treatments. Nemtabrutinib may stop cancer cell growth, while lisocabtagene maraleucel uses your own immune cells to fight cancer. You could be eligible if you have confirmed CLL/SLL with measurable disease and are able to receive lisocabtagene maraleucel. The main goal is to see how many patients have a complete response (cancer disappears) up to 5 years after treatment. The study plans to enroll 20 participants, but its current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 20 participants. It is testing two interventions: nemtabrutinib and lisocabtagene maraleucel.
- What's involved
- You would take nemtabrutinib daily for up to one year and receive lisocabtagene maraleucel after preparation. You would also have various scans, biopsies, and blood tests throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- After completing study treatment, participants will be followed for 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07194980
Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentFred Hutchinson Cancer CenterInvestigator-initiated
~20 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:NemtabrutinibLisocabtagene Maraleucel
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete response (CR)
Measured over Up to 5 years after completion of study treatment
Conditions
Where it's being run
1 sites across 1 statesWashington1
Study leadership
- Mazyar Shadman, MD, MPH · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Confirmed diagnosis of CLL/SLL per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) classification
Measurable disease by imaging (lymph node \[LN\] \> 1.5cm) or absolute lymphocyte count (ALC) (\> 5000/μL) or marrow involvement of at least 30% by flow cytometry
Eligible for lisocabtagene maraleucel (liso-cel) as standard-of-care per Food and Drug Administration (FDA) label for CLL/SLL
At least 18 years of age at time of study enrollment
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
The ability to swallow and retain oral medication
NOTE: Administration of nemtabrutinib is not permitted through a percutaneous endoscopic gastro-jejunal (J PEG) tube
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Hepatitis B screening tests should include HBsAg and anti-HBV. Hepatitis B screening tests are not required unless:
Known history of HBV infection,
As mandated by local health authority
Absolute neutrophil count (ANC) ≥ 500/µL
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 is permissible to stabilize participant prior to study treatment if needed
No lower limit if cytopenia is related to bone marrow involvement
Platelets ≥ 25 000/µL
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
Creatinine ≤ 1.5 × upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or CrCl) ≥ 30 mL/min for participant with creatinine levels \> 1.5 × institutional ULN
Creatinine clearance (CrCl) should be calculated per institutional standard
Total bilirubin ≤ 1.5 × ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 × ULN
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases)
International normalized ratio (INR) OR prothrombin time (PT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Cardiac (echocardiogram \[Echo\] or multi-gated acquisition scan \[MUGA\]) ejection fraction ≥ 40%
Exclusion
Diagnosis of Richter Transformation
Clinically significant (symptomatic) central nervous system (CNS) involvement at time of study enrollment. Previously treated CNS disease is allowed if the participant is asymptomatic. Incidental findings including positive cerebral spinal fluid (CSF) studies are not exclusionary
Active infection and uncontrolled infection
Active HBV/hepatitis C virus (HCV) infection
Participants must have completed curative anti-viral therapy for HCV at least 4 weeks prior to study enrollment
Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to study enrollment
Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention
HIV with a detectable viral load or a CD4 count ≤ 350 cells/µL at time of screening
Participants with HIV who do not meet the above criteria are eligible if they are on a stable antiretroviral therapy (ART) regimen (ART must not be strong CYP3A4 inducers) for at least 4 weeks prior to study entry and are compliant with ART are eligible
Patients with an AIDS defining opportunistic infection in the past 12 months prior to screening
Gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy)
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Corrected QT interval (QTc) prolongation (defined as a QTc \> 450 msecs) or other significant electrocardiogram (ECG) abnormalities including second degree atrioventricular (AV) block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats/min)
Known allergy/sensitivity to nemtabrutinib or any of the excipients
Known prior progressive disease while on nemtabrutinib
NOTE: Refer to the investigator's brochure (IB) for details regarding prior recipients of nemtabrutinib
History of severe bleeding disorder defined as an ongoing congenital or acquired condition that leads to an increased likelihood of bleeding
History of a second malignancy
NOTE: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder
A participant of childbearing potential (POCBP) who has a positive urine pregnancy test within 72 hours prior to study enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Note: In the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for participant to start receiving study medication
Need or anticipation of need for additional bridging therapy in addition to nemtabrutinib
Palliative radiation therapy for less than 2 weeks or the use of prednisone 30mg (or the prednisone equivalent) for a maximum of 5 days is allowed and is not exclusionary
Currently being treated with the following drugs:
P-gp substrates with a narrow therapeutic index
CYP3A strong inducers
CYP3A strong inhibitors
NOTE: A washout period of at least 5 times the half-life after the last dose of any of the above treatments is required for a participant to be eligible for study enrollment
Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of inactivated vaccines are allowed
Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
Has not adequately recovered after 4 weeks from major surgery or has ongoing surgical complications
Note: Biopsy and placement of central venous access devices are not considered major surgery
Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Any condition or history that the study investigator deems not in the best interest of the patient to participate
What this trial measures
- Complete response (CR)Up to 5 years after completion of study treatment
Will be defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. Binary proportions will be estimated along with 95% confidence intervals. Confidence intervals for binary proportions will be estimated using the Wilson Score method.