BMS-986449 Clinical Trials

Size	Price	Qty
1mg	USD 197
5mg	USD 347

Clinical Trials

A clinical trial sponsored by Bristol-Myers Squibb is evaluating BMS-986449 as a monotherapy and in combination with nivolumab for patients with advanced solid tumors. Currently active, not recruiting, this Phase 1/Phase 2 study aims to assess the safety, tolerability, and preliminary antitumor activity of the treatment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05888831	ACTIVE_NOT_RECRUITING	Advanced Solid Tumors	Bristol-Myers Squibb	2023-06-06	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2025-06-11)

Check the BMS-986449 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BMS-986449 acts as a CELMoD molecular glue that binds Cereblon to induce CRBN-mediated ubiquitination and proteasomal degradation of transcription factors IKZF2 and IKZF4 in regulatory T cells. This targeted degradation drives regulatory T cell reprogramming and enhances antitumor immune responses, providing a strong therapeutic rationale for its clinical evaluation in advanced solid tumors.

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>).