Clinical Trial

A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma

Recruiting Phase 1/2
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Summary
This study aims to evaluate the tolerability of OJP-001, a therapeutic system combining photodynamic therapy (PDT) using OMD-001 and extracorporeal circulation therapy using OJE-001 and OJC-001, in patients with adult T-cell leukemia/lymphoma (ATL). The study will also investigate the recommended dose and pharmacokinetics of OMD-001, as well as the efficacy and safety of OJP-001.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-07-10; most recent amendment 2026-04-28.
Trial Details
NCT Number NCT07075328
Lead Sponsor Otsuka Medical Devices Co., Ltd. Japan
Collaborators: JIMRO Co., Ltd.
Conditions Adult T-Cell Leukemia/Lymphoma (ATLL)
Enrollment 49 participants
Start Date 2024-04-01
Primary Completion 2028-02-28 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-29