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JAG201 Gene Therapy Study in Children & Adults With SHANK3 Haploinsufficiency

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Site contacts updated at 2 of 3 sitesv10
  2. Eligibility criteria expanded, about 19 wordsv9
  3. Site details revised at 1 of 3 sitesv8
  4. Eligibility criteria expanded, about 16 wordsv7
  5. Site contacts updated at 1 of 3 sitesv6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 2 to 3v5
  2. Site details revised at 1 of 2 sitesv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2024 to Jan 7, 2024
    • Site details revised at 2 of 2 sites
    v3
  4. Site contacts updated at 2 of 2 sitesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 1/2, first in human, open-label, dose-escalation study to evaluate the safety, tolerability, and clinical activity of a single dose of JAG201 administered via intracerebroventricular (ICV) injection in pediatric and adult participants with SHANK3 haploinsufficiency resulting from SHANK3 loss of function mutations and chromosomal deletions encompassing the SHANK3 gene. Clinical data will be evaluated for safety, tolerability, and preliminary clinical activity of JAG201 in pediatric and adult participants with SHANK3 haploinsufficiency. The pediatric cohorts will start enrolling first and the enrollment for adult cohorts may be initiated at a later timepoint in the study.
Trial Details
NCT Number NCT06662188
Lead Sponsor Jaguar Gene Therapy, LLC
Conditions
(from sponsor)		 SHANK3 Haploinsufficiency, Phelan-McDermid Syndrome
Related terms Telomeric 22q13 Monosomy Syndrome
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov