KT-413 Clinical Trials

Size	Price	Qty
1mg	USD 197
5mg	USD 347

Clinical Trials

A clinical trial sponsored by Kymera Therapeutics, Inc., evaluated the therapeutic potential of intravenously administered KT-413 in patients with aggressive hematologic malignancies, specifically Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma, and MYD88-mutated tumors. This completed, open-label, multicenter Phase 1 study characterized the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of the drug. Overall, the study aimed to evaluate the biological impact of dual IRAK4 and Ikaros/Aiolos targeted degradation in individuals with relapsed or refractory lymphoma.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05233033	COMPLETED	Non Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma; DLBCL; MYD88 Gene Mutation	Kymera Therapeutics, Inc.	2022-06-13	PHASE1

(data from https://clinicaltrials.gov, updated on 2024-12-10)

Check the KT-413 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

KT-413 operates as a dual-function PROTAC and molecular glue that selectively recruits ubiquitin ligase machinery to target interleukin-1 receptor-associated kinase 4 (IRAK4) along with the transcription factors Ikaros and Aiolos for proteasomal degradation, effectively dismantling downstream MYD88-driven NF-κB signaling networks. This targeted protein degradation halts oncogenic survival signals and triggers lymphoma cell apoptosis, providing the biological rationale for its clinical evaluation in patients with Diffuse Large B-Cell Lymphoma and other Non-Hodgkin Lymphomas harboring MYD88 gene mutations.

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>).