Limantrafin (CB-103) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Limantrafin (CB-103) has been evaluated across multiple Phase 1 and Phase 2 clinical trials targeting various oncological conditions, including lymphoblastic leukemia, advanced breast cancer, adenoid cystic carcinoma, and solid tumors. Sponsored by biopharmaceutical entities such as Cellestia Biotech AG and clinical investigators at institutions like M.D. Anderson Cancer Center, these studies exhibit recruitment statuses ranging from active recruitment to termination. For example, a clinical trial is currently recruiting patients with NOTCH-activated adenoid cystic carcinoma, whereas earlier studies have been terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05774899	RECRUITING	Adenoid Cystic Carcinoma; Metastatic Adenoid Cystic Carcinoma; Recurrent Adenoid Cystic Carcinoma	Glenn J. Hanna	2023-06-01	PHASE1; PHASE2
NCT05464836	TERMINATED	Leukemia, Lymphoblastic; Leukemia	M.D. Anderson Cancer Center	2023-04-06	PHASE2
NCT05464836	Recruiting	Leukemia Lymphoblastic\|Leukemia	M.D. Anderson Cancer Center	2023-04-06	Phase 2
NCT03422679	TERMINATED	Breast Cancer; Colorectal Cancer; Adenoid Cystic Carcinoma; Non-hodgkin Lymphoma; Glomus Tumor, Malignant; Hepatocellular Carcinoma; Osteosarcoma; T-ALL	Cellestia Biotech AG	2017-12-05	PHASE1; PHASE2
NCT04714619	TERMINATED	Advanced Breast Cancer	MedSIR	2021-05-06	PHASE2
NCT04714619	Terminated	Advanced Breast Cancer	MedSIR\|Cellestia Biotech AG	2021-05-06	Phase 2

(data from https://clinicaltrials.gov, updated on 2026-06-29)

Check the Limantrafin (CB-103) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Limantrafin (CB-103) directly binds and inhibits the Notch transcription activation complex, thereby disrupting Notch receptor-mediated downstream transcriptional activity required for neoplastic cell proliferation and survival. This targeted transcriptional block produces Notch loss-of-function phenotypes and suppresses oncogenic growth, providing the mechanistic basis for its clinical investigation in Notch-driven malignancies including lymphoblastic leukemia, advanced breast cancer, and adenoid cystic carcinoma.

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>).