Telratolimod (3M-052) Clinical Trials

Size	Price	Qty
5mg	USD 477
25mg	USD 1,470

Clinical Trials

Telratolimod (MEDI9197) was evaluated in a clinical trial sponsored by MedImmune LLC to assess the safety, tolerability, and preliminary activity of the intratumorally administered agonist as a monotherapy. This Phase I, first-in-human study targeted patients diagnosed with solid tumors, cutaneous T-cell lymphoma, and other advanced cancers. Although designed to characterize the drug's therapeutic potential, the study's recruitment status was ultimately marked as terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02556463	Terminated	Solid Tumors\|CTCL\|Cancer	MedImmune LLC	2015-11-04	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Telratolimod (3M-052) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Telratolimod functions as a selective agonist that binds Toll-like receptor 7 (TLR7) and Toll-like receptor 8 (TLR8), triggering downstream NF-κB and interferon regulatory factor signaling cascades. This molecular activation drives local immune cell activation and cytokine release in the tumor microenvironment, mediating broad antitumor activity relevant to clinical investigations in solid tumors and cutaneous T-cell lymphoma.

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>).