New hope for Tough-to-Treat blood cancers: NX-5948 trial opens
NCT ID NCT07221500
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
37 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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AUSL della Romagna UO Ematologia
RECRUITINGRavenna, 48121, Italy
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Aidport Sp. z o.o.
RECRUITINGSkorzewo, 60-185, Poland
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Azienda Ospedaliero-Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo
RECRUITINGAlessandria, 15121, Italy
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CHU de Nantes
RECRUITINGNantes, 44000, France
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Cedars-Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
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City of Hope
RECRUITINGDuarte, California, 91010, United States
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Colorado Blood Institute
RECRUITINGDenver, Colorado, 80218, United States
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Duke University
RECRUITINGDurham, North Carolina, 27705, United States
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Florida Cancer Specialists
RECRUITINGSarasota, Florida, 34232, United States
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Fort Wayne Oncology and Hematology
RECRUITINGFort Wayne, Indiana, 46804, United States
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Fred Hutchinson Cancer Center
RECRUITINGSeattle, Washington, 98109, United States
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Hematology Oncology of Indiana
RECRUITINGIndianapolis, Indiana, 46260, United States
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IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
RECRUITINGBologna, 40138, Italy
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Karmanos Cancer Center
RECRUITINGDetroit, Michigan, 48201, United States
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Maryland Oncology Hematology
RECRUITINGSilver Spring, Maryland, 20904, United States
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Novant Health Cancer Institute
RECRUITINGWinston-Salem, North Carolina, 27103, United States
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Oncology & Hematology Associates of Southwest VA
RECRUITINGNorfolk, Virginia, 23502, United States
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Oncology Hematology Care
RECRUITINGFairfield, Ohio, 45014, United States
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Ospedale San Raffaele S.r.l.
RECRUITINGMilan, 20132, Italy
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Oxford University Hospitals NHS Foundation Trust
RECRUITINGHeadington, Oxford, OX3 9D, United Kingdom
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Pratia Hematologia Sp. z o.o.
RECRUITINGKatowice, 40-519, Poland
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Pratia S.A.
RECRUITINGKrakow, 30-225, Poland
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Pratia Warszawa / Pratia MTZ
RECRUITINGWarsaw, 02-172, Poland
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SCRI Oncology Partners
RECRUITINGNashville, Tennessee, 37203, United States
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Scripps Health
RECRUITINGSan Diego, California, 92121, United States
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Texas Oncology - Center South
RECRUITINGAustin, Texas, 78705, United States
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The Christie NHS Foundation Trust
RECRUITINGManchester, M20 4BX, United Kingdom
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The Cleveland Clinic Foundation
RECRUITINGCleveland, Ohio, 44195, United States
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The Ohio State University
RECRUITINGColumbus, Ohio, 43210, United States
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The Royal Marsden NHS Foundation Trust
RECRUITINGLondon, SW3 6JJ, United Kingdom
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UPMC Hillman Cancer Center
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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University of Cincinnati
RECRUITINGCincinnati, Ohio, 45221, United States
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University of Iowa
RECRUITINGIowa City, Iowa, 52242, United States
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University of Miami
RECRUITINGCoral Gables, Florida, 33146, United States
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University of Utah
RECRUITINGSalt Lake City, Utah, 84112, United States
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Virginia Cancer Specialists, PC
RECRUITINGFairfax, Virginia, 22031, United States
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Virginia Oncology Associates
RECRUITINGNorfolk, Virginia, 23502, United States
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