NCT06980948 Safety and Tolerability Study of ST-503 for Refractory Pain Due to Peripheral Neuropathy (Small Fiber Predominant, SFN)
| NCT ID | NCT06980948 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sangamo Therapeutics |
| Condition | Chronic Neuropathic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2025-12-04 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 27 participants in total. It began in 2025-12-04 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria 1. Diagnostic characterization of Small Fiber Neuropathy (SFN) according to the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities and Networks (ACTTION) criteria. 2. Medical record documentation that pain is refractory to 2 of 3 categories of first line medical therapy for at ≥ 6 months prior to screening. 3. Serum sample negative for pre-existing anti-AAV9 antibodies determined by assay detection limit Exclusion Criteria 1. Drug- and alcohol-related: 1. Persons using opioid analgesics for under 3 months or persons who are not on a stable dose of opioids; if on a stable dose, the dose may decrease over the course of the study but should not be increased. 2. History of known alcohol abuse, opioid analgesic abuse, or illicit drug abuse within 2 years of Screening. 3. Positive urine test for drugs of abuse (including opiates, benzodiazepines, amphetamines, cocaine, barbiturates, and phencyclidine) without prescription and investigator approval, at Screening and Day -1. 4. Use of cannabinoids is not permitted. 2. Persons with Fabry's disease, with erythromelalgia, with peripheral neuropathies due to alcohol or drug toxicity, or with diagnosed channelopathies 3. Procedure-related: 1. Contraindications to LP, general anesthesia or sedation 2. Any medical disorders that, in the opinion of the Investigator, could interfere with LP including but not limited to evidence for a pressure gradient between supratentorial and infratentorial compartments, Arnold-Chiari malformation, bleeding diathesis, clinically significant coagulopathy, thrombocytopenia, increased intracranial pressure, or spine disease or past surgical procedures involving the spine 4. Infectious disease-related: 1. Active viral infection or bacterial 2. A severe infection (e.g., pneumonia, septicemia, central nervous system infections \[e.g., meningitis, encephalitis\]) within 12 weeks prior to Screening 5. Hepatic disease- and hepatotoxic medication-related: 1. Presence of clinically relevant liver disease 2. Hepatic dysfunction as indicated by one or more of the following: i. Albumin ≤ 3.5 g/dL ii. Total bilirubin \> 1.5 x ULN and direct bilirubin ≥0.5 mg/dL iii. Alkaline phosphatase (ALP) \> 2 x ULN iv. Alanine transaminase (ALT) or aspartate transaminase (AST) \> 1.5 x ULN 3. Hepatotoxic medications should be avoided during the study period including acetaminophen exceeding 4 gm/day unless essential to patient's treatment, approved by investigator, and hepatic dysfunction is not identified 4. Hepatotoxic supplement use during the study period 6. Cancer-related: a. History of cancer, including B-cell cancers, within 5 years of Screening i. Exceptions to this exclusion are fully excised non-melanoma skin cancers, non-metastatic prostate cancer, and fully treated ductal carcinoma in situ of the breast, provided subject has been stable for at least 6 months b. Previous autologous or allogeneic bone marrow transplant, peripheral stem cell transplant or solid organ transplantation 7. Previously received gene or cellular therapy
Contact & Investigator
Medical Monitor
STUDY DIRECTOR
Sangamo Therapeutics Inc.
Frequently Asked Questions
Who can join the NCT06980948 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Neuropathic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06980948 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06980948 currently recruiting?
Yes, NCT06980948 is actively recruiting participants. Contact the research team at clinicaltrials@sangamo.com for enrollment information.
Where is the NCT06980948 trial being conducted?
This trial is being conducted at Scottsdale, United States, Little Rock, United States, La Jolla, United States, Baltimore, United States and 7 additional locations.
Who is sponsoring the NCT06980948 clinical trial?
NCT06980948 is sponsored by Sangamo Therapeutics. The principal investigator is Medical Monitor at Sangamo Therapeutics Inc.. The trial plans to enroll 27 participants.