Trial intelligence / Profile preview

OTL-200 long-term insertional oncogenesis follow-up study

NL-OMON61294Phase 4Not yet recruiting

Sponsor
Orchard Therapeutics
Start
Jun 2026
Modality
Hematopoietic Stem Cells → Adult Stem Cells → Stem Cell Therapies → Cell Therapies, Gene Therapies
Countries
1
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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. Planned start Jun 2026; status: not yet recruiting.

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Drugs

atidarsagene autotemcel
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Conditions

metachromatic leukodystrophy (MLD)

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