RightFit
RecruitingPhase 1 / Phase 2

Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies

An Open-label, Multicenter Phase 1b/2 Study to Evaluate the Safety and Efficacy of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies

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 NX-5948 (bexobrutideg) with venetoclax, with or without rituximab or obinutuzumab. It is for adults with CLL or SLL, two types of blood cancer, who need their first treatment or whose cancer came back or did not respond to treatment.

The study will evaluate NX-5948 (bexobrutideg) in combination with venetoclax with or without an anti-CD20 antibody (rituximab or obinutuzumab) in second-line or higher (2L+) relapsed/refractory (R/R) or first-line (1L) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

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

Eligibility

Who can join

  • Able to do daily self-care and be up and about for at least half of waking hours (ECOG score of 0 to 2).
  • Organs and bone marrow, which makes blood cells, must work well enough.
  • Cancer must be measurable on a CT scan and meet the study's CLL guidelines.
  • If cancer came back or did not respond, past treatment must include a BTK inhibitor, a drug that blocks a protein cancer cells use.
  • If this is your first treatment, you must have confirmed CLL or SLL that needs treatment throughout the body under CLL treatment guidelines.
  • Must sign a consent form showing you understand the study and agree to join.

Who can't join

  • Known or suspected prolymphocytic leukemia, or Richter's transformation, when CLL or SLL changes into a faster-growing cancer, at any time before joining.
  • An experimental drug or cancer treatment too close to the study start: within 14 days or 5 drug half-lives, whichever is shorter. A half-life is the time it takes the body to clear half of a drug.
  • Radiation treatment within 2 weeks before the first study dose, except radiation to a small area to ease symptoms.
  • Steroid medicine affecting the whole body above 20 mg of prednisone daily, or an equal dose of another steroid, within 7 days before treatment. Steroids to prevent reactions to scan contrast dye are allowed.
  • Past treatment with a BTK degrader, a drug that breaks down the BTK protein; or a BCL-2 inhibitor, a drug that blocks a cancer survival protein, unless repeat treatment with that drug type is allowed.
  • Known lymphoma or leukemia in the brain or spinal cord.
  • A heart attack, unstable heart-related chest pain, unstable heart disease causing symptoms from poor blood flow, a heart artery stent, or another major heart condition within 6 months before treatment.
  • Blood clots blocking blood flow, a stroke, or bleeding inside the skull within 6 months before treatment.

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

Official eligibility criteria

Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Adequate organ and bone marrow function * Measurable disease by computed tomography (CT) per iwCLL * For R/R CLL/SLL, prior therapy must include treatment with a Bruton tyrosine kinase inhibitor (BTKi) * For 1L CLL/SLL, confirmed previously untreated CLL/SLL with a clinical indication for systemic treatment that meets iwCLL criteria * Must sign an informed consent form indicating understanding of the study purpose and procedures and willingness to participate Key Exclusion Criteria: * Known or suspected prolymphocytic leukemia or Richter's transformation at any time preceding enrollment * Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) prior to planned start of study treatment * Radiotherapy within 2 weeks of the first dose of study drug except for focal palliative radiation * Use of systemic corticosteroids (\>20 mg/day prednisone or equivalent) within the 7 days prior to initiation of study treatment excepting those used as prophylaxis for radiodiagnostic contrast * Previously treated with a BTK degrader * Previously treated with a BCL-2 inhibitor (BCL-2i) unless eligible for retreatment * Known central nervous system (CNS) lymphoma or leukemia * Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, placement of a coronary arterial stent, or any other significant cardiac condition within 6 months of planned start of study treatment * Thromboembolic events, stroke, or intracranial hemorrhage within 6 months of planned start of study treatment Note: Other Inclusion/Exclusion criteria may apply as defined in the protocol.

Study sites (6)

CO

FL

OR

PA

TN

TX