RecruitingPHASE2INTERVENTIONAL

A Study of NX-5948 in Adults With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor and a B-cell Lymphoma-2 Inhibitor (DAYBreak CLL-201)

This research study is investigating a new medication called NX-5948 for adults diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). These are types of blood cancer. The study is for patients whose cancer has either come back or hasn't responded to previous treatments, specifically those who have already received a type of drug called a BTK inhibitor and another called a BCL-2 inhibitor. The main goal is to find out how effective NX-5948 is at treating these conditions and to check its safety. Participants will take the drug by mouth, and their health will be regularly monitored throughout the study, which could last several years.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Nurix Therapeutics, Inc.

Enrolment target

100

Start

15 Oct 2025

Estimated completion

01 Oct 2030

Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)

What is this study about?

This study is focused on a new treatment called NX-5948 for adults living with two specific types of slow-growing blood cancer: Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). These cancers affect white blood cells, and the study is for patients whose cancer has been difficult to treat or has returned after previous therapies. Specifically, it's for those who have already tried two different kinds of drugs: a 'BTK inhibitor' and a 'BCL-2 inhibitor'.

The main aim of this study is to see if NX-5948 effectively treats CLL/SLL in these patients. It also wants to understand how safe the new drug is and how the body handles it. NX-5948 works differently from some existing treatments; it's designed to destroy a specific protein called BTK, rather than just blocking its activity. Researchers hope this approach might offer a new way to tackle the cancer.

By participating, you would help researchers understand if NX-5948 can be a new option for patients whose cancer has been challenging to control. This is a "Phase 2" study, meaning it's still in the earlier stages of testing in humans, but initial safety checks would have been done.

Key takeaways

This study evaluates a new drug, NX-5948, for CLL/SLL.
It's for adults whose cancer hasn't responded to previous treatments (BTK and BCL-2 inhibitors).
NX-5948 works by destroying a specific cancer-related protein.
The study aims to determine how well and how safely NX-5948 works.
Participants will take the drug orally with regular health check-ups.
Participation duration can be several years, as long as the treatment is beneficial.

Who may be eligible?

To join this study, you must be at least 18 years old and have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) that has either come back or not responded well to past treatments.

You must have already received treatment with a specific type of drug called a BTK inhibitor (both covalent and non-covalent types) and also a BCL-2 inhibitor. Your general health should be good enough to participate, as assessed by a doctor. If you have SLL, your disease must be measurable on scans.

There are also some reasons why you wouldn't be able to join. For example, if you have a different type of leukaemia called prolymphocytic leukaemia or if your CLL has transformed into a more aggressive lymphoma (Richter's transformation). You also can't have received certain other cancer treatments or investigational drugs too recently before the study begins, and you shouldn't have had a BTK 'degrader' drug before. Your doctor will carefully review all your medical history to see if this study is suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of CLL or SLL that has relapsed or proven difficult to treat?
Have you already received treatment with a BTK inhibitor AND a BCL-2 inhibitor?
Is your general health good enough to take part in a study?
Do you currently have another active cancer apart from your CLL/SLL, or have you had certain other treatments recently?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study drug, NX-5948, as tablets taken by mouth. You will continue taking this medication for as long as it is helping your cancer and you are tolerating it well, or until your cancer shows signs of getting worse. This could be for a period of up to five years, or even longer if it continues to work.

Throughout your participation, you will have regular medical check-ups and tests to monitor your cancer and overall health. These will be scheduled by the study team. Even if you stop taking NX-5948 but your cancer has not progressed, you'll still have follow-up check-ups until your cancer does worsen. The doctors and nurses managing the study will explain all the procedures and tests involved in detail.

Potential risks and benefits

Participating in this study might offer the potential benefit of accessing a new treatment (NX-5948) that could help control your CLL or SLL, especially if previous treatments haven't been successful. However, as with any new medication, there are potential risks and side effects that are not yet fully known. The study aims to gather more information on these. You will be closely monitored for any unwanted effects, and your safety is a top priority. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (24)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

City of Hope
Verified postcode
Duarte, United States· Recruiting
Colorado Blood Institute
Verified postcode
Denver, United States· Recruiting
Florida Cancer Specialists
Verified postcode
Sarasota, United States· Recruiting
University of Iowa
Verified postcode
Iowa City, United States· Recruiting
Maryland Oncology Hematology
Verified postcode
Silver Spring, United States· Recruiting
Novant Health Cancer Institute
Verified postcode
Winston-Salem, United States· Recruiting
University of Cincinnati
Verified postcode
Cincinnati, United States· Recruiting
Oncology Hematology Care
Verified postcode
Fairfield, United States· Recruiting
SCRI Oncology Partners
Verified postcode
Nashville, United States· Recruiting
Texas Oncology - Center South
Verified postcode
Austin, United States· Recruiting
Virginia Cancer Specialists, PC
Verified postcode
Fairfax, United States· Recruiting
Oncology & Hematology Associates of Southwest VA
Verified postcode
Norfolk, United States· Recruiting

Common questions

What kind of cancer is this study for?

This study is for adults with a type of blood cancer called Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

What is NX-5948?

NX-5948 is a new experimental drug being tested in this study. It works by targeting and destroying a specific protein involved in these cancers.

Have I had to have previous treatments to join?

Yes, you must have previously been treated with both a 'BTK inhibitor' and a 'BCL-2 inhibitor' for your CLL/SLL.

How long will I be in the study?

Participation could last for up to 5 years, or possibly even longer, as long as the treatment is working and your cancer is not getting worse.

Will I receive the new drug, or a placebo?

All patients in this study will receive the new drug, NX-5948, there is no placebo group.

How to find out more

Additional Site Contact Information

clinicaltrials@nurixtx.com 415-417-3418 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.