A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies

ConditionsChronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)Diffuse Large B Cell Lymphoma (DLBCL)Follicular Lymphoma (FL)Mantle Cell Lymphoma (MCL)Marginal Zone Lymphoma (MZL)Waldenstrom Macroglobulinemia (WM)Primary Central Nervous System Lymphoma (PCNSL)Secondary Central Nervous System Lymphoma (SCNSL)

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorNurix Therapeutics, Inc.

About this trial

This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of NX-5948 in patients with advanced B-cell malignancies.

Eligibility criteria

Qualifiers

Age ≥18 years

Patients in Phase 1a (Dose Escalation) must have histologically confirmed R/R CLL, SLL, DLBCL (subgroups include Richter-transformed DLBCL, germinal center B-cell type, activated B-cell type, high-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangements, high-grade B-cell lymphomas NOS), FL, MCL, MZL (subtypes include EMZL, MALT, NMZL, SMZL), WM, or PCNSL.

Patients in Phase 1b (Safety and Cohort Expansion) must have 1 of the following histologically documented B-cell malignancies, must meet criteria for systemic treatment, and must have received prior therapies and/or molecular features based on details described for each cohort: CLL or SLL, DLBCL, MCL, FL, MZL, WM, or PCNSL/SCNSL.

Measurable disease per response criteria specific to the malignancy.

Disqualifiers

Known or suspected active prolymphocytic leukemia or Richter's transformation to Hodgkin's lymphoma prior to study enrollment

Radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation).

Prior systemic chemotherapy within 2 weeks of planned start of study drug.

Prior monoclonal antibody therapy within 4 weeks of planned start of study drug, except for patients enrolling in Cohort 16 (CLL with secondary wAIHA) where a 16-week washout period is required.

Trial design

Treatments tested in this trial

NX-5948

Treatment groups

572 Participants

are divided into 19 treatment groups

Treatment groups

See each treatment group below.

Locations

France

CHU Angers49933, Angers France

Hôpital Avicenne93009, Bobigny France

CHU de Nantes44093, Nantes France

CHU Bordeaux33604, Pessac France

Sponsors and collaborators

Nurix Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov