drugset / Trial / NCT06789445

A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)

NCT06789445 ↗

Phase 1/2 Recruiting 54 enrolled BlueRock Therapeutics
Non-randomizedSequentialOpen-labelTreatment

Summary

Study OpCT-001-101 is a Phase 1/2a first-in-human, multisite, 2-part interventional study to evaluate the safety, tolerability, and the effect on clinical outcomes of OpCT-001 in approximately 54 adults with primary photoreceptor (PR) disease. Phase 1 focuses on safety and features a dose-escalation design. Phase 2 is designed to gather additional safety data and assess the effect of OpCT-001 on measures of visual function, functional vision, and anatomic measures of engraftment in different clinical subgroups.

Timeline

Start
2025-03-10
Primary completion
2029-10
Completion
2030-10

Drugs

EvaluationDrugModalityDoseRoute
Subject OpCT-001 Cell therapy — Other