CC-90009 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple Phase I clinical trials sponsored by Celgene evaluate CC-90009, focusing on safety, pharmacokinetics, and exploratory efficacy. These studies include dose-finding, combination therapy, and metabolic evaluations in healthy volunteers as well as patients with relapsed or refractory acute myeloid leukemia and myelodysplastic syndromes. Recruitment statuses across these early-phase trials range from active not recruiting to terminated or completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04336982	TERMINATED	Leukemia, Myeloid, Acute	Celgene	2020-08-05	PHASE1
NCT02848001	TERMINATED	Leukemia, Myeloid, Acute; Myelodysplastic Syndromes	Celgene	2016-11-14	PHASE1
NCT04297124	COMPLETED	Healthy Volunteer	Celgene	2020-03-11	PHASE1
NCT02848001	Active not recruiting	Leukemia Myeloid Acute\|Myelodysplastic Syndromes	Celgene	2016-11-14	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-31)

Check the CC-90009 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CC-90009 functions as a novel cereblon E3 ligase modulator that selectively induces the ubiquitination and proteasomal degradation of G1 to S phase transition 1 (GSPT1), thereby disrupting protein translation termination and inducing selective cell cycle arrest. This targeted protein degradation triggers apoptosis in vulnerable malignant cells, providing a strong rationale for its therapeutic application in acute myeloid leukemia and myelodysplastic syndromes.

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>).