A Study of NX-2127 for B-cell Malignancies
This study is testing a new oral medication called NX-2127 in adults with certain types of B-cell cancers that have returned or not responded to previous treatments. These cancers include Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Waldenstrom Macroglobulinemia (WM), Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL). The main goals are to find a safe dose of NX-2127 and to see how well it works against these cancers. You might be able to join if you are at least 18 years old and have measurable disease that requires treatment. The study is looking for about 248 participants.
- Study design
- This is a Phase 1a/1b, open-label study, meaning both you and the study team will know which treatment you are receiving. It will enroll about 248 participants and has two parts: a dose-finding phase and a dose optimization phase.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track safety for up to 24 months and evaluate how well the treatment works for up to 4 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04830137
A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies
Recruiting
PHASE1Ages 18+InterventionalTreatmentNurix Therapeutics, Inc.
~248 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:NX-2127
At a glance
Recruiting sites
7 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Protocol Specified Dose-Limiting Toxicities
Measured over Up to 24 months
+3 more outcomes measured
Conditions
Where it's being run
16 sites across 11 statesCalifornia3
Florida2
Ohio2
Texas2
Colorado1
Illinois1
Maryland1
New York1
Study leadership
- Study Director · STUDY_DIRECTOR · Nurix Therapeutics, Inc.
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients must be ≥ 18 years of age
Patients must have measurable disease per disease-specific response criteria
Patients with indolent forms of NHL must meet the criteria requiring systemic treatment (i.e., iwCLL, IWG, Lugano Classification of Lymphoma response criteria, or International PCNSL Collaborative Group response criteria)
Have histologically confirmed R/R CLL, SLL, WM, MCL, and MZL, FL, DLBCL, or PCNSL
Received at least 2 prior systemic therapies (or at least 1 prior therapy for patients with WM or PCNSL) and have no other therapies known to provide clinical benefit
Must require systemic therapy
Must have one of the following histologically documented R/R B-cell malignancies:
CLL/SLL whose disease has failed treatment with a BTKi;
MCL whose disease has failed treatment with BTKi and an anti-CD20 mAb-based regimen
FL or MZL whose disease has failed treatment with an anti-CD20 mAb-based regimen; or WM whose disease has failed treatment with a BTKi
PCNSL whose disease failed at least 1 prior line of treatment
DLBCL 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 (either progressed post stem cell transplant or transplant-ineligible)
Active known second malignancy. Exception: patients with non-metastatic, non-melanoma skin cancer are eligible
Patient has had major surgery (e.g. requiring general anesthesia) within 4 weeks before the planned first dose of study drug
Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: patients with well-controlled HIV (e.g., CD4 \> 350/mm3 and undetectable viral load) are eligible.
Current active liver disease from any cause
Active viral reactivation (e.g., CMV or EBV)
Use of systemic corticosteroids exceeding 20 mg/day prednisone (or equivalent) for non-PCNSL indications within 15 days prior to the planned start of study drug. PCNSL patients may not exceed corticosteroid doses of 40 mg/day prednisone (or equivalent) and should be on a stable or decreasing dose for 7 days prior to planned study start.
Use of non-steroidal immunosuppressive drugs within 30 days prior to start of the study
Clinically significant, uncontrolled cardiac, cardiovascular disease, or history of myocardial infarction within 6 months of planned start of study drug
Administration of any strong cytochrome P450 3A (CYP3A) inducers or inhibitors for 14 days prior to the first dose of study drug, and any P-glycoprotein inhibitors (for 2 days) or moderate inducers of CYP3A for 7 days
Exclusion
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (non-PCNSL indications) or 0 - 2 (PCNSL patients)
Adequate organ and bone marrow function
Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol
Active, uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia
History of known/suspected other autoimmune disease (exception(s): patients with alopecia, vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed.)
Unable to swallow capsules or have a condition that may interfere in the delivery, absorption, or metabolism of the study drug
Bleeding diathesis, or other known risk for acute blood loss
Patients requiring ongoing treatment with warfarin or an equivalent vitamin K antagonist and within 7 days prior to the first dose of study drug
Prior radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation)
What this trial measures
- Number of Participants with Protocol Specified Dose-Limiting ToxicitiesUp to 24 months
Phase 1a
- To establish the MTD and/or recommended Phase 1b dosage(s) of NX-2127Up to 24 months
Phase 1a
- 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 InvestigatorUp to 4 years
Phase 1b
- Number of Participants with Adverse Events and Clinical Laboratory AbnormalitiesUp to 5 years
Phase 1a/1b