RecruitingPhase 1Phase 2NCT07075328

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.


Sponsor

Otsuka Medical Devices Co., Ltd. Japan

Enrollment

49 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called OJP-001 in patients with adult T-cell leukemia/lymphoma (ATL) — a rare and aggressive blood cancer caused by the HTLV-1 virus — whose cancer has come back or not responded to previous treatment. **You may be eligible if...** - You are between 20 and 85 years old - You have a confirmed diagnosis of aggressive ATL (acute, lymphoma type, or chronic with unfavorable factors) - You are HTLV-1 antibody positive - Your cancer has relapsed after previous treatment including mogamulizumab, OR you cannot tolerate mogamulizumab, OR you relapsed after a stem cell transplant - You have cancer cells in your blood (peripheral blood lesion) - You are in reasonably good health (ECOG 0–2) with a life expectancy of more than 3 months **You may NOT be eligible if...** - You have indolent (slow-growing) ATL - Your organ function (liver, kidneys) is significantly impaired - Your expected survival is less than 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDrug: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.


Locations(5)

National Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Sapporo Hokuyu Hospital

Sapporo, Hokkaido, Japan

Imamura general hospital

Kagoshima, Kagoshima-ken, Japan

University of Miyazaki Hospital

Miyazaki, Miyazaki, Japan

Nagasaki University Hospital

Nagasaki, Nagasaki, Japan

View Full Details on ClinicalTrials.gov

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NCT07075328