Study of NX-5948 in adults with relapsed or resistant chronic lymphocytic leukemia and small lymphocytic lymphoma who previously received BTK inhibitor and BCL-2 inhibitor treatment

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What is this study about?

This study focuses on patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that has returned or not responded to previous treatments. These are types of blood cancers that affect certain white blood cells. The study will test a new medication called NX-5948, which is taken as a capsule by mouth, in patients who have already been treated with two specific types of cancer medicines: a Bruton’s Tyrosine Kinase inhibitor and a B-cell Lymphoma-2 inhibitor.

The purpose of this research is to determine how well NX-5948 works in treating adults with CLL or SLL that has come back or not responded to previous treatments. During the study, participants will receive NX-5948 capsules daily. The maximum daily dose that may be given is 600 milligrams, and treatment may continue for up to 28 days per treatment cycle.

Throughout the study, doctors will monitor participants’ health through regular check-ups and various medical tests. They will look at how the cancer responds to the treatment and keep track of any side effects that may occur. The study will collect information about how long the treatment effects last and how it affects participants’ overall health.

1 Initial evaluation

Your eligibility for the study will be assessed based on specific criteria, including confirmation of relapsed/refractory CLL/SLL (types of blood cancer)

Medical tests will be performed to verify your organ and bone marrow function

Your previous treatment history will be reviewed to confirm you have received both a BTK inhibitor and a BCL-2 inhibitor

2 Treatment initiation

You will begin taking NX-5948 in capsule form by mouth

Your disease will be measured through radiographic assessment before starting treatment

3 Ongoing monitoring

Regular assessments will track your response to treatment

Blood tests will be conducted to measure NX-5948 levels in your blood

Your vital signs and laboratory values will be monitored throughout the study

Any side effects or health changes will be documented

4 Response evaluation

Your response to treatment will be evaluated by both study doctors and independent reviewers

Regular scans will be performed to measure how your disease responds to treatment

The time it takes for your disease to respond will be recorded

5 Long-term follow-up

Your health status will continue to be monitored even after completing treatment

The duration of your response to treatment will be tracked

Your overall survival will be monitored throughout the study period

Who Can Join the Study?

Must be 18 years of age or older
Must have confirmed relapsed/refractory CLL/SLL (chronic lymphocytic leukemia or small lymphocytic lymphoma that has returned or stopped responding to previous treatments) that requires treatment according to established medical criteria
Must have an ECOG performance status of 0-2 (a measure of a person’s ability to perform daily activities and self-care, where 0 means fully active and 2 means able to do light activities but unable to work)
Must have previously received treatment with both:
- a BTK inhibitor (a type of medication that blocks specific proteins in cancer cells)
- a BCL-2 inhibitor (a type of medication that helps trigger cancer cell death)
Must have disease that can be measured by imaging tests (such as CT scans)
Must have adequate organ and bone marrow function (meaning your major organs and blood-forming cells are working well enough)

Who Cannot Join the Study?

Prior diagnosis of Richter’s transformation (a rare condition where CLL changes into an aggressive lymphoma)
Active or uncontrolled autoimmune conditions (diseases where the body’s immune system attacks its own tissues)
History of other cancers within the past 3 years, except for successfully treated non-melanoma skin cancer or localized cancers
Known active central nervous system involvement by leukemia or lymphoma
Major surgery within 4 weeks before starting the study treatment
Significant heart problems, including:
- Heart attack within the past 6 months
- Uncontrolled irregular heartbeat
- Severe heart failure
Active, uncontrolled infections requiring treatment
Known infection with HIV, hepatitis B, or hepatitis C
Pregnancy or breastfeeding
Unable to swallow oral medications
Current participation in other investigational drug studies
Any condition that, in the opinion of the study doctor, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Mtz Clinical Research Powered By Pratia	Warsaw	Poland
Pratia Hematologia Sp. z o.o.	Katowice	Poland
University Of Debrecen	Debrecen	Hungary
Pratia S.A.	Skorzewo	Poland
Centre Hospitalier Universitaire De Nantes	Nantes	France
IRCCS Azienda Ospedaliero Universitaria – Policlinico di Sant’Orsola	Bologna	Italy
Ozkhokeh Sfznw Maiqg dtqyk Cotuo	Ravenna	Italy
Afbugke Syg z osvw	Poznan	Poland
Acvgurj Oozdabumapt Ngllaasyy Sy Acrlmwd E Bjxdvg E C Abibyu Atourqsqqjp	Alexandria	Italy

Trial status

Country	Status	Recruitment Start
France	Recruiting	30.10.2025
Hungary	Not recruiting	30.10.2025
Italy	Recruiting	30.10.2025
Poland	Recruiting	30.10.2025

Trial locations

NX-5948 is an investigational medication being studied for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It is designed to work in patients whose cancer has returned or become resistant to previous treatments. This medication is being tested in patients who have already been treated with two other types of cancer medications: BTK inhibitors and BCL-2 inhibitors. NX-5948 is taken orally and represents a new approach to treating these blood cancers.

Investigated diseases:

B-cell small lymphocytic lymphoma

Chronic Lymphocytic Leukemia (CLL) – A slow-growing blood cancer that affects white blood cells called lymphocytes. The abnormal lymphocytes gradually increase in number, primarily in the blood and bone marrow. Over time, these cells can spread to the lymph nodes, liver, and spleen, causing them to enlarge. CLL typically develops over months or years, and some people may not experience symptoms in the early stages.

Small Lymphocytic Lymphoma (SLL) – A type of lymphoma that is essentially the same disease as CLL but manifests differently in the body. In SLL, the abnormal lymphocytes mainly accumulate in the lymph nodes rather than in the blood and bone marrow. The disease develops slowly, and the abnormal cells can cause lymph nodes to become enlarged. SLL and CLL are considered different manifestations of the same condition.

Trial ID:

2025-521088-10-00

Protocol code:

NX-5948-201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of NX-5948 in adults with relapsed or resistant chronic lymphocytic leukemia and small lymphocytic lymphoma who previously received BTK inhibitor and BCL-2 inhibitor treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?