RecruitingPHASE1INTERVENTIONAL

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

This research study is about a new drug called NX-5948, designed for adults who have different kinds of B-cell blood cancers, including certain lymphomas and leukemias. These are cancers that have either returned after treatment (relapsed) or haven't gotten better with previous therapies (refractory). The study has two main parts. The first part (Phase 1a) focuses on finding the safest and best dose of NX-5948 by starting with small amounts and carefully watching for side effects. The second part (Phase 1b) will then look more closely at how well that chosen dose works against the cancer and continue to monitor for safety in specific groups of patients. If you have been diagnosed with one of these B-cell cancers and your current treatments aren't working, this study might be an option to discuss with your doctor.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Nurix Therapeutics, Inc.

Enrolment target

572

Start

13 Apr 2022

Estimated completion

01 Jan 2028

Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)Diffuse Large B Cell Lymphoma (DLBCL)Follicular Lymphoma (FL)Mantle Cell Lymphoma (MCL)Marginal Zone Lymphoma (MZL)Waldenstrom Macroglobulinemia (WM)Primary Central Nervous System Lymphoma (PCNSL)Secondary Central Nervous System Lymphoma (SCNSL)

What is this study about?

This study is looking into a new treatment called NX-5948 for adults diagnosed with certain types of blood cancers, specifically those affecting B-cells. These cancers include different forms of lymphoma (like Diffuse Large B-cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, and Lymphoma in the brain) and leukemia (Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Waldenstrom Macroglobulinemia). All the patients taking part in this study have cancers that have either come back after past treatments or haven't improved with the therapies they've already tried. The main goal is to see if NX-5948 is safe and if it can help fight the cancer.

The study is split into different stages. The first stage, called Phase 1a, will involve a small group of patients and will try out different doses of NX-5948. Doctors will start with a very low dose and slowly increase it, while carefully checking for any side effects. This helps them find the safest dose that patients can handle. Once a safe dose is found, the study moves on to Phase 1b.

In Phase 1b, more patients will receive the chosen safe dose of NX-5948. This stage will look more closely at how well the new medicine works against the cancer in different groups of patients with specific types of B-cell cancers. They will also continue to watch for any side effects. This step helps researchers understand if NX-5948 could be a helpful treatment option for these difficult-to-treat cancers.

Key takeaways

This study is for adults with specific B-cell blood cancers that have returned or haven't responded to past treatments.
It's testing an experimental drug, NX-5948, for safety and effectiveness.
The study aims to find the best dose and then see how well it works in different patient groups.
Regular clinic visits, blood tests, and scans will monitor your health.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults aged 18 or older. To be considered, you must have a confirmed diagnosis of certain B-cell blood cancers, such as specific types of lymphoma or leukemia, that have either returned or not responded to at least two previous treatments. If your cancer is in the brain (Primary Central Nervous System Lymphoma), you need to have had at least one prior treatment. Your general health and organ function will be checked to ensure you can safely take part.

There are also some reasons why you might not be able to join the study. For example, if you have certain other serious health conditions, or if you've recently had other cancer treatments like chemotherapy, radiation, or certain antibodies within a specific timeframe before the study drug is planned to start. The study also cannot accept patients with a fast-growing form of leukemia called prolymphocytic leukemia or a specific transformation of Richter's lymphoma.

It's important that your cancer can be measured by doctors to see if the treatment is working. Your doctor will carefully review all your medical history and test results to see if this study is right for you, based on all these detailed criteria.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of one of the listed B-cell cancers (e.g., certain lymphomas or leukemias)?
Has your cancer come back or not responded to at least two previous treatments (or one if it's in the brain)?
Are you generally well enough to participate, as assessed by your doctor?
Have you discussed any recent cancer treatments with your doctor to check for time limits?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study involves receiving the experimental drug, NX-5948. The study begins by finding the right dose, which means some patients might start with a lower dose that could be increased. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These visits are essential to make sure the treatment is safe for you and to see if it's working.

The exact schedule and number of visits will depend on which part of the study you are in and how you respond to the treatment. You will also have follow-up appointments after you stop taking the study drug to continue monitoring your health. The total duration of your participation in the study will vary, but it could involve ongoing treatment as long as it is safe and effective, followed by a follow-up period. All specific details about visits, tests, and medication will be fully explained by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit: you could receive a new treatment, NX-5948, for your cancer that has not responded to previous therapies or has returned. This treatment may help to control or shrink your cancer, though there is no guarantee it will work for everyone. As with any new medicine, there are potential risks, including side effects from NX-5948, which could range from mild to serious. The study team will monitor you very closely for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (62)

City of Hope
Duarte, United States· Recruiting
University of California, San Francisco
San Francisco, United States· Recruiting
Colorado Blood Cancer Institute
Denver, United States· Recruiting
Yale Cancer Center
New Haven, United States· Recruiting
University of Miami
Miami, United States· Recruiting
Florida Cancer Specialists
Sarasota, United States· Recruiting
Winship Cancer Institute of Emory University
Atlanta, United States· Recruiting
Northwestern University
Chicago, United States· Recruiting
National Institute of Health
Bethesda, United States· Recruiting
Cayuga Medical Center
Ithaca, United States· Withdrawn
Memorial Sloan Kettering Cancer Center
New York, United States· Active not recruiting
Duke University Medical Center
Durham, United States· Recruiting

+50 more sites — see the official record for the full list.

Common questions

What is a 'B-cell malignancy'?

B-cell malignancies are types of cancer that start in immune system cells called B-cells. These include common blood cancers like certain lymphomas and leukemias.

What does 'relapsed/refractory' mean?

It means your cancer has either come back after previous treatments (relapsed) or it hasn't responded well to the treatments you've received before (refractory).

Is NX-5948 a new type of treatment?

Yes, NX-5948 is an experimental medicine. This is the first time it is being tested in humans to see if it's safe and effective for these types of cancer.

What is the difference between Phase 1a and Phase 1b?

Phase 1a mainly focuses on finding the safest dose of the new drug. Phase 1b then uses that safe dose to see how well it works against the cancer in more patients, while continuing to check for safety.

Will I definitely get the new drug if I join?

Yes, in this study, all participants who meet the criteria will receive the new drug, NX-5948. There is no placebo group.

How to find out more

Additional Site Contact Information

clinicaltrials@nurixtx.com +1 (415) 417-3418 Official trial record

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