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

ConditionsB-cell LymphomaChronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNurix Therapeutics, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • NX-5948

    Drug

    Administered orally once daily as a capsule

  • venetoclax

    Drug

    Administered orally once daily as a tablet per prescribing information

  • rituximab

    Drug

    Administered as an intravenous (IV) infusion per prescribing information

  • obinutuzumab

    Drug

    Administered as an IV infusion per prescribing information

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: NX-5948 + venetoclaxExperimental treatment 2 interventions
Group B: NX-5948 + venetoclax + rituximabExperimental treatment 3 interventions
Group C: NX-5948 + venetoclax + obinutuzumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of participants with treatment-emergent adverse events

Time frame
Up to approximately 7 years

Secondary outcomes

1

Objective response rate as determined by investigator

The percentage of participants with response as determined according to 2018 iwCLL guidelines; response includes complete response (CR)/CR with incomplete marrow recovery (CRi), partial response (PR), PR with lymphocytosis (PR-L), and nodular PR

Time frame
Up to approximately 7 years
2

Duration of response as determined by investigator

Time from the date of the first response to the date of documented progressive disease or death due to any cause, whichever is earlier

Time frame
Up to approximately 7 years
3

Progression-free survival as determined by investigator

Time from the date of the first dose of study drug to the date of documented progressive disease or death due to any cause, whichever is earlier

Time frame
Up to approximately 7 years
4

Complete response rate as determined by investigator

The percentage of participants with CR or CRi as determined according to 2018 iwCLL guidelines; includes CR + CRi for participants with CLL.

Time frame
Up to approximately 7 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nurix Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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