BMS-986299 Clinical Trials

Size	Price	Qty
5mg	USD 159
25mg	USD 477

Clinical Trials

A Phase 1 clinical trial sponsored by Bristol-Myers Squibb evaluated BMS-986299 as monotherapy or in combination with nivolumab and ipilimumab in participants with advanced solid cancers. Designed to assess safety and preliminary efficacy, the study has since terminated recruitment. This evaluation constitutes the recorded clinical trial experience for BMS-986299 in human subjects.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03444753	TERMINATED	Advanced Cancer	Bristol-Myers Squibb	2018-04-05	PHASE1

(data from https://clinicaltrials.gov, updated on 2022-05-23)

Check the BMS-986299 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BMS-986299 functions as a novel agonist of the NLRP3 inflammasome, stimulating downstream interleukin-8 (IL-8) secretion to promote the activation and recruitment of natural killer (NK) cells. This immune-mediated pathway enhances cytotoxic innate immune responses against malignant cells, providing the mechanistic basis for evaluating BMS-986299 in the treatment of advanced cancers.

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>).