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.
Otsuka Medical Devices Co., Ltd. Japan
49 participants
Apr 1, 2024
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
Plain Language Summary
Simplified for easier understanding
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
\[Phase I part\] 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)
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NCT07075328