NX-5948 for Chronic Lymphocytic Leukemia

Recruiting at 9 trial locations

Overseen By Additional Site Contact Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Nurix Therapeutics, Inc.

Must be taking: BTK inhibitors, BCL-2 inhibitors

Must not be taking: Anticancer therapy, Immunosuppressive drugs

Disqualifiers: Prolymphocytic leukemia, Richter's transformation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 5 years

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, NX-5948, for individuals with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) whose disease has returned or not responded to previous treatments. The goal is to determine if this drug can effectively treat CLL/SLL after other treatments, such as BTK inhibitors and BCL-2 inhibitors, have been used. Individuals previously treated with specific CLL/SLL drugs who still have measurable disease might be suitable for this trial. Participants will be involved for up to 5 years, provided their condition does not worsen. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before starting the study drug. Antibody therapy must stop at least 4 weeks before, and no other systemic anticancer therapy is allowed during the study, except for some hormonal therapies for breast and prostate cancer.

Is there any evidence suggesting that NX-5948 is likely to be safe for humans?

Research has shown that NX-5948 appears safe in early studies. Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who received this treatment found it well-tolerated. These studies included individuals whose previous treatments were ineffective.

The results indicated few serious side effects. Most side effects were mild and manageable, meaning that while some participants experienced issues, they weren't severe enough to halt the treatment.

Since this trial is in a later stage, NX-5948 has already passed initial safety checks, providing some confidence in its safety for humans. However, as with any treatment, some risk remains. Nonetheless, the data so far suggests that NX-5948 is generally safe for most patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for chronic lymphocytic leukemia (CLL) involve chemotherapy, targeted therapies like ibrutinib, or monoclonal antibodies such as rituximab. But NX-5948 works differently, targeting a specific protein involved in the cancer cell's survival, which could mean fewer side effects and more precise action against cancer cells. Researchers are excited about NX-5948 because it offers a novel approach that could improve outcomes for patients who may not respond well to existing treatments. This fresh mechanism of action has the potential to provide a new lifeline for those battling CLL.

What evidence suggests that NX-5948 might be an effective treatment for chronic lymphocytic leukemia?

Research has shown that NX-5948, the treatment under study in this trial, appears promising for chronic lymphocytic leukemia (CLL). It breaks down a protein called Bruton's tyrosine kinase (BTK), which aids cancer cell survival. Studies have found that NX-5948 targets both regular and altered forms of this protein. Early results suggest it might benefit patients with CLL who have already tried other treatments, potentially offering a new option for those in need. ^{1 2 6 7}

Who Is on the Research Team?

Nurix Study Director

Principal Investigator

Nurix Therapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have already been treated with a BTK inhibitor and a BCL-2 inhibitor. Participants should be able to perform daily activities with ease to moderate difficulty (ECOG 0-2), have measurable disease, good organ and bone marrow function, and must understand the study procedures and agree to participate.

Inclusion Criteria

I am 18 years old or older.

I am willing to sign a consent form to participate in the study.

My CLL/SLL has come back or didn't respond to treatment and needs more therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NX-5948 orally until their cancer progresses or other stopping criteria are met

Up to 5 years

Regular health check-ups

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Open-label extension (optional)

Participants may continue to receive NX-5948 if their cancer has not progressed

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• NX-5948

Trial Overview

The trial is testing NX-5948 (bexobrutideg) as a treatment for CLL/SLL in patients whose disease has returned or did not respond after previous treatments. The study will evaluate how well this drug works over a period of up to five years or more if the patient's condition does not worsen.

How Is the Trial Designed?

Group I: NX-5948 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Nurix Therapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

1,100+

Citations

1.

ir.nurixtx.com

ir.nurixtx.com/news-releases/news-release-details/nurix-therapeutics-presents-new-data-demonstrating-durable

Press releases

The new and updated data from the Phase 1a/1b study (NX-5948-301) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and ...

2.

ashpublications.org

ashpublications.org/blood/article/144/Supplement%201/884/530858/Efficacy-and-Safety-of-the-Bruton-s-Tyrosine

Efficacy and Safety of the Bruton's Tyrosine Kinase (BTK ...

NX-5948 is a novel, orally administered small molecule that induces specific protein degradation of wild type and mutant forms of Bruton's tyrosine kinase (BTK)

3.

onclive.com

onclive.com/view/nx-5948-demonstrates-preliminary-efficacy-in-high-risk-cll

NX-5948 Demonstrates Preliminary Efficacy in High-Risk ...

NX-5948, a novel BTK degrader, has demonstrated promising early efficacy in patients with chronic lymphocytic leukemia (CLL), positioning it as a potential ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0006497124036310

Efficacy and Safety of the Bruton's Tyrosine Kinase (BTK) ...

NX-5948 is a novel, orally administered small molecule that induces specific protein degradation of wild type and mutant forms of Bruton's tyrosine kinase (BTK)

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05131022

A Study of NX-5948 in Adults With Relapsed/Refractory B- ...

This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of NX-5948 in patients with advanced ...

6.

onclive.com

onclive.com/view/novel-btk-degrader-nx-5948-yields-high-response-rates-in-pretreated-cll-sll

Novel BTK Degrader NX-5948 Yields High Response ...

Nirav N. Shah, MD, MSHP, details how BTK degraders could fill an unmet need in pretreated CLL/SLL and highlights promising data seen with NX-5948.

7.

cllsociety.org

cllsociety.org/2024/10/btk-degrader-offers-promise-in-relapsed-and-refractory-cll/

BTK Degrader Offers Promise in Relapsed and Refractory ...

Very early findings from this ongoing first-in-human study of NX-5948 demonstrate an encouraging safety in NHL and chronic lymphocytic leukemia.