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

> **NCT07236606** · PHASE3 · SUSPENDED · sponsor: **REGENXBIO Inc.** · enrollment: 2 (estimated)

## Conditions studied

- MPS II
- Hunter Syndrome (MPS II)

## Interventions

- **GENETIC:** RGX-121-3102

## Key facts

- **NCT ID:** NCT07236606
- **Lead sponsor:** REGENXBIO Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** SUSPENDED
- **Start date:** 2025-11-25
- **Primary completion:** 2028-04-30
- **Final completion:** 2031-05-30
- **Target enrollment:** 2 (ESTIMATED)
- **Why stopped:** 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.
- **Last updated:** 2026-02-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07236606

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07236606, "RGX-121-3102 Gene Therapy in Participants With MPS II (Hunter Syndrome)". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT07236606. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*