Clinical Trials

Multiple clinical trials sponsored by academic institutions, including Thomas Jefferson University and the University of Texas Southwestern Medical Center, evaluate the immunotherapeutic potential of 3',3'-cGAMP across oncological and autoimmune indications. These include an active, recruiting study investigating STING agonist activity in relapse-remitting multiple sclerosis and a completed trial exploring innate immune activation in solid malignancies, such as urothelial carcinoma, melanoma, and cervical carcinoma in situ. Given their translational and early exploratory nature, the phases for these studies are listed as unspecified or not applicable.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05705986 Recruiting
Relapse Remitting Multiple Sclerosis
Thomas Jefferson University
 2021-02-26 --
NCT02986867 Completed
Urothelial Carcinoma|Melanoma|Cervical Carcinoma in Situ
University of Texas Southwestern Medical Center
 2017-06-13 Not Applicable

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

Check the 3',3'-cGAMP product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

3',3'-cGAMP directly binds to and activates the endoplasmic reticulum-resident receptor stimulator of interferon genes (STING), triggering downstream signaling cascades that induce the secretion of type I interferons and stimulate innate immune responses. This immune activation enhances cellular defense mechanisms, providing a therapeutic rationale for suppressing tumor growth in urothelial carcinoma, melanoma, and cervical carcinoma as well as modulating neuroinflammatory pathology in relapse-remitting multiple sclerosis.

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>).

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Note: Technical data last updated: Sep 1, 2026.