New hope for Tough-to-Treat blood cancers: NX-5948 trial opens

NCT ID NCT07221500

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 6 times

Summary

This study tests an experimental drug called NX-5948 in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or not responded to prior treatments, including BTK and BCL-2 inhibitors. The main goal is to see if the drug can shrink or control the cancer. About 100 participants will take the drug, and the study lasts up to 5 years or longer if the disease stays under control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age: ≥ 18 years * Confirmed relapsed/refractory CLL/SLL that meets iwCLL criteria for diagnosis and systemic treatment * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Must have received a covalent BTK inhibitor (BTKi), a non-covalent BTKi, and a BCL-2 inhibitor either in separate lines of therapy or in combination; a line of therapy is considered 2 or more consecutive cycles of a systemic anti-CLL/SLL regimen * Participants with SLL must have measurable disease by radiographic assessment * Adequate organ and bone marrow function * Must sign an informed consent form indicating that he or she understands the purpose of the procedures required for the study and is willing to participate Exclusion Criteria: * Known or suspected prolymphocytic leukemia or Richter's transformation before entering study * Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) before planned start of study drug * Antibody therapy must stop at least 4 weeks before the first dose of study drug * No other systemic anticancer therapy is allowed at the same time as this study; exception: continuation of hormonal therapy for breast and prostate cancer is allowed, if they are not on the list of prohibited concomitant medications in this study * Palliative limited-field radiotherapy within 7 days of the first dose of study or broad field radiotherapy within 28 days of first dose of study drug * Use of systemic corticosteroids \>20 mg/day prednisone or equivalent within the 7 days before start of study drug except for those used as premedication for radio diagnostic contrast * Use of systemic immunosuppressive drugs other than systemic corticosteroids within 60 days before the first dose of study drug * Previously treated with a BTK degrader * Previous chimeric antigen receptor (CAR) T-cell therapy or allogeneic or autologous hematopoietic cell transplant within the past 90 days prior to enrollment * Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), stroke, or intracranial hemorrhage within 6 months of planned start of study drug Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic lymphocytic leukemia, CLL are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    37 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AUSL della Romagna UO Ematologia

    RECRUITING

    Ravenna, 48121, Italy

  • Aidport Sp. z o.o.

    RECRUITING

    Skorzewo, 60-185, Poland

  • Azienda Ospedaliero-Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo

    RECRUITING

    Alessandria, 15121, Italy

  • CHU de Nantes

    RECRUITING

    Nantes, 44000, France

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Colorado Blood Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Fort Wayne Oncology and Hematology

    RECRUITING

    Fort Wayne, Indiana, 46804, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Hematology Oncology of Indiana

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

    RECRUITING

    Bologna, 40138, Italy

  • Karmanos Cancer Center

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Maryland Oncology Hematology

    RECRUITING

    Silver Spring, Maryland, 20904, United States

  • Novant Health Cancer Institute

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Oncology & Hematology Associates of Southwest VA

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • Oncology Hematology Care

    RECRUITING

    Fairfield, Ohio, 45014, United States

  • Ospedale San Raffaele S.r.l.

    RECRUITING

    Milan, 20132, Italy

  • Oxford University Hospitals NHS Foundation Trust

    RECRUITING

    Headington, Oxford, OX3 9D, United Kingdom

  • Pratia Hematologia Sp. z o.o.

    RECRUITING

    Katowice, 40-519, Poland

  • Pratia S.A.

    RECRUITING

    Krakow, 30-225, Poland

  • Pratia Warszawa / Pratia MTZ

    RECRUITING

    Warsaw, 02-172, Poland

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Scripps Health

    RECRUITING

    San Diego, California, 92121, United States

  • Texas Oncology - Center South

    RECRUITING

    Austin, Texas, 78705, United States

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The Royal Marsden NHS Foundation Trust

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45221, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Miami

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Virginia Cancer Specialists, PC

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Virginia Oncology Associates

    RECRUITING

    Norfolk, Virginia, 23502, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.