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

NCT07075328 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2026-04-29

No results posted yet for this study

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.

Conditions

  • Adult T-Cell Leukemia/Lymphoma (ATLL)

Interventions

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.

Sponsors & Collaborators

  • JIMRO Co., Ltd.

    collaborator INDUSTRY

  • Otsuka Medical Devices Co., Ltd. Japan

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2028-02-28
Completion
2028-08-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07075328 on ClinicalTrials.gov