NCT06212297

Active Not RecruitingPhase 1/2

Fellow-eye Study (FE) of LX101 in Subjects With Inherited Re...

Innostellar Biotherapeutics Co.,Ltd Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

INNOSTELLAR-LX101-2

Study Type

interventional

Estimated enrollment

9

Locations

1 country

Sites

1

Timeline

Study Start

September 12, 2023

Actual (reported)

Primary Completion

February 6, 2025

Actual (reported)

Study Completion

March 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief Summary

Up to nine subjects who have participated in the earlier LX101 clinical study, and who meet all study eligibility criteria, will receive LX101 administration in the previously uninjected, contralateral eye to evaluate the safety of bilateral, sequential subretinal administration of LX101.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: active not recruiting
Estimated enrollment: 9 participants
Study completion date: March 2029
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 12, 2023
Actual (reported)
First Submitted
December 25, 2023
Actual (reported)
First Posted
January 18, 2024
Actual (reported)
Primary Completion
February 6, 2025
Actual (reported)
Study Completion
March 2029
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: June 29, 2025
Status Verified: June 2025
Last Update Submitted: June 27, 2025

Conditions

Inherited Retinal Dystrophy

Keywords

RPE65 Mutations

Outcome Measures

Primary Outcomes (1)

Safety: Incidence of adverse events (AEs) and serious adverse events (SAEs)
Incidence of ocular and non-ocular AEs and SAEs following LX102 subretinal injection
6 months

Secondary Outcomes (3)

Full-field Light Sensitivity Threshold (FST) Test
6 months、12 months
Visual Acuity
6 months、12 months
Mobility Test
6 months、12 months

Study Arms (1)

LX101 Subretinal Administration

EXPERIMENTAL

Genetic: LX101

Interventions

LX101GENETIC

Subretinal administration of LX101 to the contralateral, previously uninjected eye

LX101 Subretinal Administration

Eligibility Criteria

Age6 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Prior subretinal administration of LX101 (unilateral)
≥ 6 years old Signed written informed consent

You may not qualify if:

Sponsors & Collaborators

Innostellar Biotherapeutics Co.,Ltdlead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 25, 2023

First Posted

January 18, 2024

Study Start

September 12, 2023

Actual (reported)

Primary Completion

February 6, 2025

Actual (reported)

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Phase 3Completed

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Phase 2Completed

Prior gene therapy except LX101 Active intraocular or periocular infections Lacking of sufficient surviving retinal cells Prior ocular surgery within six months Retinoid like compounds or precursors were taken within three months Complicating systemic diseases Clinically significant abnormal baseline laboratory values Using of any retinal toxic compounds

Contact the study team to confirm eligibility.

Study Completion

March 2029

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

June 29, 2025

Record last verified: 2025-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Open registry record

Source retrieved: 2026-10-25 22:33:47 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

LX101 Subretinal Administration

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Design

Study Record Dates

Source record

Locations