Clinical Trials

NX-5948 is currently being evaluated in several clinical trials sponsored by Nurix Therapeutics, Inc., spanning Phase 1 through Phase 3 across active and completed recruitment statuses. The clinical program investigates the compound in healthy volunteers and patients with diverse B-cell malignancies, including CLL, SLL, DLBCL, MCL, FL, MZL, WM, and central nervous system lymphomas. Key studies encompass Phase 1 dose-escalation and pharmacokinetic evaluations as well as Phase 2 and Phase 3 comparative trials in relapsed or refractory populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07520006 RECRUITING
B-cell Lymphoma; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
Nurix Therapeutics, Inc.
 2026-08 PHASE1; PHASE2
NCT07516093 RECRUITING
B-cell Lymphoma; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
Nurix Therapeutics, Inc.
 2026-08-03 PHASE3
NCT07221500 RECRUITING
Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)
Nurix Therapeutics, Inc.
 2025-10-15 PHASE2
NCT05131022 RECRUITING
Chronic 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)
Nurix Therapeutics, Inc.
 2022-04-13 PHASE1
NCT06717269 COMPLETED
Healthy Volunteer
Nurix Therapeutics, Inc.
 2024-11-30 PHASE1
NCT06691828 COMPLETED
Healthy Volunteer
Nurix Therapeutics, Inc.
 2024-11-01 PHASE1
NCT06593457 COMPLETED
Healthy Volunteers
Nurix Therapeutics, Inc.
 2024-08-20 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-28)

Check the NX-5948 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

NX-5948 acts as a targeted degrader by simultaneously binding Bruton's tyrosine kinase (BTK) and recruiting the cereblon E3 ubiquitin ligase, thereby driving the ubiquitination and subsequent proteasomal degradation of BTK to suppress downstream B-cell receptor signaling. This persistent elimination of BTK disrupts oncogenic survival cascades, rendering the compound therapeutically relevant for inhibiting tumor growth and survival in patients with B-cell malignancies such as chronic lymphocytic leukemia and non-Hodgkin lymphomas.

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.