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RecruitingPhase 2

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)

A Single-arm, Phase 2, Open-label, Multicenter Study to Evaluate NX-5948 in Adults With Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Previously Exposed to a Bruton's Tyrosine Kinase Inhibitor (BTKi) and a B-cell Lymphoma-2 Inhibitor (BCL-2i)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether NX-5948 (bexobrutideg) works to treat CLL or SLL, two types of blood cancer. It is for adults whose cancer came back or did not respond after treatment with both types of BTK inhibitors and a BCL-2 inhibitor. Taking part may last up to 5 years or longer if the cancer does not get worse.

This is a study for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with a BTK inhibitor (covalent and non-covalent) and a BCL-2 inhibitor. The main purpose of this study is to test if NX-5948 (bexobrutideg) works to treat patients with CLL/SLL. Participation could last up to 5 years, and possibly longer, if the disease does not progress.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • You have confirmed CLL or SLL that came back or did not respond to treatment, and you meet standard rules for needing treatment throughout the body.
  • You can care for yourself and are up and about for at least half of your waking hours, even if you cannot work.
  • You have received a covalent BTK inhibitor, a non-covalent BTK inhibitor, and a BCL-2 inhibitor. These cancer drugs may have been given together or separately, for at least 2 treatment cycles in a row per treatment course.
  • If you have SLL, your cancer can be measured on scans.
  • Your organs and bone marrow, which makes blood cells, work well enough for the study.
  • You understand the study procedures and sign a form agreeing to take part.

Who can't join

  • You have or may have prolymphocytic leukemia, another type of blood cancer, or Richter's transformation, when CLL/SLL changes into a faster-growing cancer.
  • You recently received an experimental drug or cancer treatment: within 14 days or 5 drug half-lives, whichever is shorter. A half-life is the time for half a drug to leave the body. Antibody treatment must stop at least 4 weeks before study treatment. Other cancer drugs that act throughout the body are not allowed during the study, except certain hormone treatments for breast or prostate cancer.
  • You had radiation to a small area to ease symptoms within 7 days, or radiation to a large area within 28 days, before starting the study drug.
  • You took steroids that act throughout the body at more than 20 mg a day of prednisone, or an equal dose of another steroid, within 7 days before study treatment. Steroids given before scan contrast dye are allowed.
  • You took other drugs that lower the body's immune defenses within 60 days before the first study dose.
  • You have received a BTK degrader, a drug that breaks down the BTK protein.
  • You had CAR T-cell therapy, which uses changed immune cells to fight cancer, or a blood-forming cell transplant using your own or a donor's cells within 90 days before joining.
  • You had certain blood clots, a stroke, or bleeding inside the skull within 6 months before the planned start of the study drug. Other study rules may also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (27)

AZ

CA

CO

FL

IA

IN

MD

MI

NC

OH

PA

TN

TX

UT

VA

WA

WI