NCT07075328

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

A Phase I/II Study of OJP-001 for Recurrent or Relapsed Adult T-cell Leukemia/Lymphoma Patients With Peripheral Blood Tumor.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Otsuka Medical Devices Co., Ltd. Japan · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

\[Phase I part\] Patients will receive 5-ALA administered orally once. After administration of 5-ALA, patients will receive OJP-001 once. Dosage of 5-ALA: 10 mg/kg (1st cohort), 20 mg/kg (2nd cohort), 40 mg/kg (3rd cohort), 60 mg/kg (4th cohort) \[Phase II part\] Patients will receive 5-ALA and OJP-001 once a week for 6 months.

Conditions

• Adult T-Cell Leukemia/Lymphoma (ATLL)

Interventions

Type	Name	Description
OTHER	Drug:5-ALA, Device:Photodynamic system	\[Phase I part\] Patients will receive 5-ALA administered orally once. After administration of 5-ALA, patients will receive Photodynamic system once. Dosage of 5-ALA: 10 mg/kg (1st cohort), 20 mg/kg (2nd cohort), 40 mg/kg (3rd cohort), 60 mg/kg (4th cohort) \[Phase II part\] Patients will receive 5-ALA and Photodynamic system once a week for 6 months.

Timeline

• Start date: 2024-04-01
• Primary completion: 2028-02-28
• Completion: 2028-08-31
• First posted: 2025-07-20
• Last updated: 2025-11-21

Locations

4 sites across 1 country: Japan