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

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.

Trial Details

NCT ID
NCT07075328
Phase
PHASE1 / PHASE2
Sponsor
Otsuka Medical Devices Co., Ltd. Japan
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Drug:5-ALA, Device:Photodynamic system
Locations (sample)
  • Fukuoka, Fukuoka, Japan|33.6,130.41667
  • Sapporo, Hokkaido, Japan|43.06667,141.35
  • Kagoshima, Kagoshima-ken, Japan|31.56667,130.55
  • Miyazaki, Miyazaki, Japan|31.91667,131.41667
  • Nagasaki, Nagasaki, Japan|32.75,129.88333

Key Eligibility Criteria

  • Hematocytologically or pathohistologically proven adult T-cell leukemia/lymphoma with positivity of anti-HTLV-1 antibody (Aggressive subtypes: acut…
  • Age: 20-85
  • Meeting the any following criteria for screening
  • Relapsed or recurrent ATL have history of treatment with mogamulizumab

For full eligibility, visit ClinicalTrials.gov.

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