A Phase 1 interventional study of NX-2127 in Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL) and Waldenstrom Macroglobulinemia (WM), sponsored by Nurix Therapeutics, Inc.. Recruiting at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Nurix Therapeutics, Inc. · Phase 1, Interventional, and Treatment
This is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-2127 in patients with advanced B-cell malignancies.
Phase 1a (Dose Escalation) will evaluate the safety and tolerability of NX-2127 in adult patients with relapsed/refractory (R/R) B-cell malignancies, who have required and received at least 2 prior systemic therapies (or at least 1 prior therapy for patients with WM or PCNSL) and for which no other therapies are known to provide clinical benefit.
Phase 1b (Dose Optimization) will use a 2-stage design to further investigate the safety, tolerability, and preliminary efficacy of NX-2127 in R/R B-cell malignancies based on the dosage(s) selected in Phase 1a.
Stage 1 will enroll approximately 10 participants per group based on B-cell lymphoma/leukemia indication at a specific dose selected from the first part of the study. The Sponsor may decide to open Stage 2 for any given group after review of safety and anti-tumor activity data from Stage 1.
In Stage 2, an additional 10 participants will be enrolled at the dose from Stage 1 as well as 20 additional participants at a second alternative dose. Participants will be randomly assigned to one of the 2 dose levels in Stage 2.
1,603 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 243 are open to participants now.
This study's planned enrollment of 248 is above the median of 40 across 1,325 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →Nurix Therapeutics, Inc. is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion Criteria for Patients in Phase 1a:
Inclusion Criteria for Patients in Phase 1b:
Must have one of the following histologically documented R/R B-cell malignancies:
Exclusion Criteria:
Multiple dose levels of NX-2127 to be evaluated; determination of MTD/Phase 1b recommended dose
Drug: NX-2127
CLL/SLL patients whose disease has failed treatment with a BTK inhibitor
Drug: NX-2127
MCL patients whose disease has failed treatment with a BTK inhibitor and an anti-CD20 monoclonal antibody (mAb) based regimen
Drug: NX-2127
FL or MZL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen; or WM whose disease has failed treatment with a BTK inhibitor
Drug: NX-2127
DLBCL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen and either: an anthracycline-based regimen; or an anti-CD19-based regimen; or another/palliative regimen
Drug: NX-2127
PCNSL patients whose disease has failed at least 1 prior line of treatment
Drug: NX-2127
CLL/SLL patients whose disease has failed treatment with a BTK inhibitor
Drug: NX-2127
MCL patients whose disease has failed treatment with a BTK inhibitor and an anti-CD20 monoclonal antibody (mAb) based regimen
Drug: NX-2127
FL or MZL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen; or WM whose disease has failed treatment with a BTK inhibitor
Drug: NX-2127
DLBCL patients whose disease has failed treatment with an anti-CD20 mAb-based regimen and either: an anthracycline-based regimen; or an anti-CD19-based regimen; or another/palliative regimen
Drug: NX-2127
PCNSL patients whose disease has failed at least 1 prior line of treatment
Drug: NX-2127
Oral NX-2127
Number of Participants with Protocol Specified Dose-Limiting Toxicities
Phase 1a
Time frame: Up to 24 months
To establish the MTD and/or recommended Phase 1b dosage(s) of NX-2127
Phase 1a
Time frame: Up to 24 months
To evaluate the clinical activity of NX-2127 at the recommended Phase 1b dosage(s) based on overall response rate (ORR) as assessed by the Investigator
Phase 1b
Time frame: Up to 4 years
Number of Participants with Adverse Events and Clinical Laboratory Abnormalities
Phase 1a/1b
Time frame: Up to 5 years
Pharmacokinetic (PK) Profile of NX-2127: Maximum Serum Concentration
Phase 1a/1b - Sampling following the first dose, pre and post-dose at selected cycles, and at the end of treatment
Time frame: Up to 5 years
Duration of response (DOR) as assessed by the Investigator
Phase 1a/1b
Time frame: Up to 5 years
Progression-free survival (PFS) as assessed by the Investigator
Phase 1a/1b
Time frame: Up to 5 years
Overall survival (OS) as assessed by the Investigator
Phase 1b
Time frame: Up to 4 years
To further evaluate the safety and tolerability of NX-2127 by collecting adverse events, treatment emergent adverse events, and incidence of all deaths
Phase 1b
Time frame: Up to 4 years
Complete response (CR) rate / CR with incomplete marrow recovery as assessed by the Investigator
Phase 1a/1b
Time frame: Up to 5 years
Plan to share: No
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Leukemia, Lymphocytic, Chronic, B-Cell→
Nurix Therapeutics, Inc.