Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06980948

Safety and Tolerability Study of ST-503 for Refractory Pain Due to Peripheral Neuropathy (Small Fiber Predominant, SFN)

Led by Sangamo Therapeutics · Updated on 2026-04-30

27

Participants Needed

11

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research is being done to study a possible treatment for refractory pain due to small fiber neuropathy (SFN). ST-503 is intended to deliver a modified copy of the gene which will ideally repress Nav1.7 tissue-related pain signals reaching the brain, which should reduce the refractory pain due to small fiber neuropathy (SFN).

CONDITIONS

Official Title

Safety and Tolerability Study of ST-503 for Refractory Pain Due to Peripheral Neuropathy (Small Fiber Predominant, SFN)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnostic confirmation of Small Fiber Neuropathy (SFN) using ACTTION criteria
  • Pain that has not improved after at least 6 months of treatment with 2 of 3 first-line therapies
  • Negative blood test for anti-AAV9 antibodies before enrollment
Not Eligible

You will not qualify if you...

  • Using opioid pain medicines for less than 3 months, or not on a stable opioid dose
  • History of alcohol, opioid, or illicit drug abuse within 2 years before screening
  • Positive drug test without prescription or approval
  • Use of cannabinoids is not allowed
  • Having Fabry's disease, erythromelalgia, alcohol or drug-related peripheral neuropathy, or diagnosed channelopathies
  • Medical reasons preventing lumbar puncture or anesthesia
  • Active viral or bacterial infections
  • Severe infection within 12 weeks before screening
  • Significant liver disease or abnormal liver function tests
  • Use of liver-toxic medications or supplements during the study
  • History of cancer within 5 years except certain stable skin, prostate, or breast cancers
  • Previous gene or cellular therapy treatment
  • History of bone marrow, stem cell, or organ transplant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

HonorHealth

Scottsdale, Arizona, United States, 85260

Actively Recruiting

2

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

Actively Recruiting

3

The University of California, San Diego

La Jolla, California, United States, 92093

Not Yet Recruiting

4

Johns Hopkins University

Baltimore, Maryland, United States, 21218

Not Yet Recruiting

5

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

6

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03766

Not Yet Recruiting

7

Columbia University Irving Medical Center (CUIMC) and New York-Presbyterian Hospital (NYPH)

New York, New York, United States, 10027

Actively Recruiting

8

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States, 27514

Not Yet Recruiting

9

Vanderbilt University

Nashville, Tennessee, United States, 37235

Not Yet Recruiting

10

University of Utah

Salt Lake City, Utah, United States, 84112

Not Yet Recruiting

11

Virginia Commonwealth University

Richmond, Virginia, United States, 23284

Actively Recruiting

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Research Team

P

Patient Advocacy

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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