Phase I/IIa Trial of scAAV1.tMCK.NTF3 for Treatment of CMT1A

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Nationwide Children's Hospital
Study ID
NCT03520751
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Charcot-Marie-Tooth Neuropathy Type 1A

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • scAAV1.tMCK.NTF3 — DRUG
    gene vector

Study Details

This clinical trial is an open-label one-time injection dose study in which scAAV1.tMCK.NTF3 will be administered by intramuscular injections into muscles in both legs in CMT1A subjects with PMP22 gene duplication. Three subjects ages 18 to 35 years receiving (8.87e11 vg/kg) will be enrolled.

Key Dates

Start date
Apr 30, 2027
Status verified
Jun 2025
Primary completion
Apr 30, 2029
Completion
Apr 30, 2030

Study Design

Enrollment
3 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose (8.87e11 vg/kg)
    Three patients age 18-35 will receive intramuscular injection of recombinant AAV1 carrying a human NFT3 gene under the control of the tMCK promoter (scAAV1.tMCK.NTF3) distributed bilaterally between both limbs at a dose of 8.87e11 vg/kg.

Primary Outcome Measure

Safety based on number of participants with adverse events. [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205
Dawn Scott
(614)722-2715

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