Clinical Trials

Sponsored by Nurix Therapeutics Inc., several Phase 1 clinical trials are evaluating the safety, tolerability, and dose escalation profile of the targeted degrader NX-2127 in adult patients with relapsed or refractory B-cell malignancies. Evaluated conditions include chronic lymphocytic leukemia, small lymphocytic lymphoma, Waldenstrom macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma, follicular lymphoma, diffuse large B-cell lymphoma, and primary central nervous system lymphoma. Recruitment across these studies currently encompasses both active, non-recruiting cohorts and actively recruiting cohorts.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04830137 RECRUITING
Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL); Waldenstrom Macroglobulinemia (WM); Mantle Cell Lymphoma (MCL); Marginal Zone Lymphoma (MZL); Follicular Lymphoma (FL); Diffuse Large B-cell Lymphoma (DLBCL); Primary Central Nervous System Lymphoma (PCNSL)
Nurix Therapeutics, Inc.
 2021-05-05 PHASE1
NCT04830137 Active not recruiting
Chronic Lymphocytic Leukemia (CLL)|Small Lymphocytic Lymphoma (SLL)|Waldenstrom Macroglobulinemia (WM)|Mantle Cell Lymphoma (MCL)|Marginal Zone Lymphoma (MZL)|Follicular Lymphoma (FL)|Diffuse Large B-cell Lymphoma (DLBCL)|Primary Central Nervous System Lymphoma (PCNSL)
Nurix Therapeutics Inc.
 2021-05-05 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-03-20)

Check the NX-2127 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

NX-2127 catalyzes the targeted ubiquitylation and proteasomal degradation of Bruton's tyrosine kinase (BTK), which abolishes downstream B-cell receptor signaling pathways while concurrently stimulating T-cell activation and elevating interleukin-2 production. This targeted depletion of BTK halts oncogenic cell proliferation, offering therapeutic efficacy against B-cell malignancies such as chronic lymphocytic leukemia and diffuse large B-cell lymphoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.