Study design & results
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
OTL-200 Long-term Insertional Oncogenesis Monitoring Study
2025-522275-28-00Phase 4Authorised
- Sponsor
- Orchard Therapeutics
- Start
- Jun 2026
- Modality
- Hematopoietic Stem Cells → Adult Stem Cells → Stem Cell Therapies → Cell Therapies, Gene Therapies
- Countries
- 6
01
Overview
Phase 4, open-label, single-arm trial of atidarsagene autotemcel in metachromatic leukodystrophy (MLD), sponsored by Orchard Therapeutics. Primary endpoint: Incidence of malignancies due to insertional oncogenesis reported during the study. Planned start Jun 2026; status: authorised.
02
Drugs
atidarsagene autotemcel
03
Conditions
metachromatic leukodystrophy (MLD)
Beyond the preview
Go deeper on 2025-522275-28-00.
Study design, results and competitive context are available in the Gosset platform where reported.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on 2025-522275-28-00.