Recruiting PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT06063850

AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy (GenTLE)

A Multi-center, Phase 1/2a, First-in-human (FIH) Study Investigating the Safety, Tolerability, and Efficacy of AMT-260 in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy (MTLE) Administered Via Magnetic Resonance Imaging (MRI)-Guided Convection-enhanced Delivery (CED)

Sponsor: UniQure Biopharma B.V.

Conditions Mesial Temporal Lobe Epilepsy

Interventions AAV9-hSyn1-miGRIK2

Updated 12 times since 2023 Last updated: Dec 3, 2025 Started: Jun 12, 2024 Primary completion: Nov 30, 2026 Completion: Dec 31, 2031

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1/PHASE2 clinical study on Mesial Temporal Lobe Epilepsy, this trial is actively recruiting participants. The trial is conducted by UniQure Biopharma B.V. and has accumulated 12 data snapshots since 2024. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

12 versions recorded

Jan 2026 — Present [monthly]

Recruiting PHASE1/PHASE2
Dec 2025 — Jan 2026 [monthly]

Recruiting PHASE1/PHASE2
Oct 2025 — Dec 2025 [monthly]

Recruiting PHASE1/PHASE2
Sep 2025 — Oct 2025 [monthly]

Recruiting PHASE1/PHASE2
Aug 2025 — Sep 2025 [monthly]

Recruiting PHASE1/PHASE2

▶ Show 7 earlier versions

Jun 2025 — Aug 2025 [monthly]

Recruiting PHASE1/PHASE2
Jan 2025 — Jun 2025 [monthly]

Recruiting PHASE1/PHASE2
Dec 2024 — Jan 2025 [monthly]

Recruiting PHASE1/PHASE2
Sep 2024 — Dec 2024 [monthly]

Recruiting PHASE1/PHASE2
Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE1/PHASE2

Phase: PHASE1_PHASE2 → PHASE1/PHASE2
Dec 2023 — Jul 2024 [monthly]

Recruiting PHASE1_PHASE2

Status: Not Yet Recruiting → Recruiting
Nov 2023 — Dec 2023 [monthly]

Not Yet Recruiting PHASE1_PHASE2

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

UniQure Biopharma B.V.

Data source: UniQure Biopharma B.V.

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

Study Locations

Austin, United States , Baltimore, United States , Bethesda, United States , Birmingham, United States , Boston, United States , Cleveland, United States , Columbus, United States , Grand Rapids, United States , Hackensack, United States , Jacksonville, United States and 8 more locations