Clinical Trials

A clinical trial sponsored by Epizyme, Inc. evaluated the safety, tolerability, and preliminary activity of EZM0414 in patients with relapsed or refractory multiple myeloma and diffuse large B-cell lymphoma. This Phase 1/1b study, which explored SETD2 inhibition as a targeted interventional strategy for relapsed hematologic malignancies, has a recruitment status recorded as terminated. Overall, these data reflect preliminary efforts by an industry sponsor to investigate this therapeutic mechanism.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05121103 TERMINATED
Multiple Myeloma, Refractory; Diffuse Large B-Cell Lymphoma; Diffuse Large B Cell Lymphoma Refractory; Multiple Myeloma in Relapse
Epizyme, Inc.
 2022-05-31 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-06-22)

Check the EZM0414 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

EZM0414 selectively binds to and inhibits histone-lysine N-methyltransferase SETD2, thereby preventing the trimethylation of histone H3 at lysine 36 and disrupting downstream transcriptional regulation and chromatin structure. This epigenetic disruption impairs cellular proliferation and induces apoptosis, offering a targeted therapeutic strategy for hematologic malignancies such as relapsed or refractory multiple myeloma 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.