deltatrials
Suspended PHASE3 INTERVENTIONAL 1-arm NCT07236606

RGX-121-3102 Gene Therapy in Participants With MPS II (Hunter Syndrome)

A Phase 3, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of RGX 121 in Pediatric Participants With Neuronopathic MPS II (Hunter Syndrome)

Sponsor: REGENXBIO Inc.

Conditions Hunter Syndrome (MPS II) MPS II
Interventions RGX-121-3102
Updated 2 times since 2025 Last updated: Feb 25, 2026 Started: Nov 25, 2025 Primary completion: Apr 30, 2028 Completion: May 30, 2031
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Suspended

The FDA placed a clinical hold on RGX-121, for the treatment of MPSII, following the report of a single case of neoplasm (intraventricular CNS tumor) in a participant treated with RGX-111 for the treatment of MPSI four years prior.

This PHASE3 trial investigates Hunter Syndrome (MPS II) and MPS II and is currently suspended. REGENXBIO Inc. leads this study, which shows 2 recorded versions since 2025 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Dec 2025 – ~Feb 2026 · 2 months · monthly snapshotRecruiting~Feb 2026 – present · 4 months · monthly snapshotSuspended

Change History

2 versions recorded

  1. Feb 2026 — Present [monthly]

    Suspended PHASE3

    Status: Recruiting → Suspended

  2. Dec 2025 — Feb 2026 [monthly]

    Recruiting PHASE3

    First recorded

Nov 2025

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • REGENXBIO Inc.
Data source: REGENXBIO Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations