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NX-2127

Phase 1

Chronic Lymphocytic Leukemia (CLL) | Small molecule | Oncology |Nurix Therapeutics, Inc.|Last Updated: Mar 20, 2026

Target and mechanism

Molecular targetBTK
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment248

FDA Designations

No designations recorded

Clinical trial landscape

NX-2127 · 1 trial · 8 indications

Phase 1 1
NCT04830137A Study of NX-2127 in Adults With Relapsed/Refractory B-cell MalignanciesChronic Lymphocytic Leukemia (CLL)
RECRUITING248 Analytics
PHASE1RECRUITING
A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies
Chronic Lymphocytic Leukemia (CLL)Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Protocol Specified Dose-Limiting Toxicities
Up to 24 months

Phase 1a

To establish the MTD and/or recommended Phase 1b dosage(s) of NX-2127
Up 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 Investigator
Up to 4 years

Phase 1b

Number of Participants with Adverse Events and Clinical Laboratory Abnormalities
Up to 5 years

Phase 1a/1b

Secondary Endpoints

Pharmacokinetic (PK) Profile of NX-2127: Maximum Serum Concentration
Up to 5 years
Duration of response (DOR) as assessed by the Investigator
Up to 5 years
Progression-free survival (PFS) as assessed by the Investigator
Up to 5 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1a Dose EscalationEXPERIMENTALMultiple dose levels of NX-2127 to be evaluated; determination of MTD/Phase 1b recommended dose
Phase 1b Dose Optimization Stage 1 in CLL or SLL (Dose A)EXPERIMENTALCLL/SLL patients whose disease has failed treatment with a BTK inhibitor
Phase 1b Dose Optimization Stage 1 in MCL (Dose A)EXPERIMENTALMCL patients whose disease has failed treatment with a BTK inhibitor and an anti-CD20 monoclonal antibody (mAb) based regimen
Phase 1b Dose Optimization Stage 1 in FL, MZL or WM (Dose A)EXPERIMENTALFL 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
Phase 1b Dose Optimization Stage 1 in DLBCL (Dose A)EXPERIMENTALDLBCL 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
Phase 1b Dose Optimization Stage 1 in PCNSL (Dose A)EXPERIMENTALPCNSL patients whose disease has failed at least 1 prior line of treatment
Phase 1b Dose Optimization Stage 2 in CLL or SLL (Randomized to Dose A or Dose B)EXPERIMENTALCLL/SLL patients whose disease has failed treatment with a BTK inhibitor
Phase 1b Dose Optimization Stage 2 in MCL (Randomized to Dose A or Dose B)EXPERIMENTALMCL patients whose disease has failed treatment with a BTK inhibitor and an anti-CD20 monoclonal antibody (mAb) based regimen
Phase 1b Dose Optimization Stage 2 in FL, MZL or WM (Randomized to Dose A or Dose B)EXPERIMENTALFL 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
Phase 1b Dose Optimization Stage 2 in DLBCL (Randomized to Dose A or Dose B)EXPERIMENTALDLBCL 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
Phase 1b Dose Optimization Stage 2 in PCNSL (Randomized to Dose A or Dose B)EXPERIMENTALPCNSL patients whose disease has failed at least 1 prior line of treatment

Interventions

NameTypeDescription
NX-2127DRUGOral NX-2127
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * 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, o...

Countries:United States
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Frequently asked questions about NX-2127

What is NX-2127 used for in Chronic Lymphocytic Leukemia (CLL)?

NX-2127 is an investigational small molecule being studied for the treatment of Chronic Lymphocytic Leukemia (CLL). It is currently in Phase 1 clinical development, and the ongoing trial also includes patients with other B-cell malignancies such as Small Lymphocytic Lymphoma, Waldenstrom Macroglobulinemia, Mantle Cell Lymphoma, and others.

What does NX-2127 target?

NX-2127 targets BTK, a protein involved in B-cell receptor signaling. By targeting BTK, NX-2127 is designed to interfere with pathways that support the survival and proliferation of malignant B-cells, which is relevant in diseases like Chronic Lymphocytic Leukemia.

Who makes NX-2127?

NX-2127 is being developed by Nurix Therapeutics, Inc., a biopharmaceutical company. Nurix Therapeutics is publicly traded under the ticker symbol NRIX on the NASDAQ stock exchange.

What phase is NX-2127 in?

NX-2127 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial is currently recruiting participants to evaluate the safety and efficacy of NX-2127 in adults with relapsed or refractory B-cell malignancies.

What clinical trials is NX-2127 in?

NX-2127 is being evaluated in a Phase 1 clinical trial with the identifier NCT04830137. This study is titled 'A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies' and is currently recruiting participants in the United States. The trial is designed to enroll approximately 248 patients.

Is NX-2127 the same as other BTK inhibitors?

NX-2127 is a distinct investigational BTK-targeting agent developed by Nurix Therapeutics. While it shares the same molecular target as other BTK inhibitors, NX-2127 is a unique small molecule with its own chemical structure and is being studied specifically in the context of relapsed or refractory B-cell malignancies.