Tests OJP-001 light-based therapy in adults with adult T-cell leukemia/lymphoma
Tests OJP-001, a light-based treatment with blood circulation, in adults with adult T-cell leukemia/lymphoma.
Plain-language title generated from the registry record
Registry title: A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma
Key facts
- Where
- Fukuoka, Kagoshima, Miyazaki, Nagasaki, and Sapporo, JapanSee the 5 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 85 years old?
Source: NCT07075328, who can take part
Where in Japan
- National Kyushu Cancer CenterFukuoka, JapanTaking people
- Imamura General HospitalKagoshima, JapanTaking people
- University of Miyazaki HospitalMiyazaki, JapanTaking people
- Nagasaki University HospitalNagasaki, JapanTaking people
- Sapporo Hokuyu HospitalSapporo, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Otsuka Medical Devices Co., Ltd. Japan
- Trial code
- NCT07075328
- Record updated
- 29 April 2026
- Original description
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.Read full original descriptionShow less
A Phase I/II Study of OJP-001 for Recurrent or Relapsed Adult T-cell Leukemia/Lymphoma Patients With Peripheral Blood Tumor.
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.
Inclusion: Hematocytologically or pathohistologically proven adult T-cell leukemia/lymphoma with positivity of anti-HTLV-1 antibody (Aggressive subtypes: acute, lymphoma type, or chronic type with unfavorable factor); Age: 20-85; Meeting the any following criteria for screening; Relapsed or recurrent ATL have history of treatment with mogamulizumab; At least one regimen of chemotherapy in case of intolerance/contraindication for mogamulizumab; Relapsed or recurrent ATL judged inadequate of treatment with mogamulizumab by investigators; Relapsed or recurrent ATL after allogeneic hematopoietic stem cell transplantation; Having peripheral blood lesion; ECOG performance status: 0-2; T-Bil: =< ULNx2, AST and ALT: =< ULNx2.5; Expected more than 3 months of survival.
Exclusion: Subjects who received an following therapy; Chemotherapy or molecular-targeted agent for ATL : within 28 days prior to registration; Radiotherapy : within 28 days prior to registration; Any investigational drugs or medical devices (unapproved in Japan) : within 28 days prior to registration; Autologous stem cell transplantation : within 84 days prior to registration; Allogenic stem cell transplantation : within 100 days prior to registration; Administrated 5-ALA drug except study drug within 7 days prior to registration; Ate the foods containing 5-ALA or St. John's wort within 7 days prior to registration; Synchronous or metachronous malignancy; Uncontrolled cardiac arrhythmia or Chronic congestive heart failure (NYHA Class III or IV); Uncontrolled inter-current illness including: heart failure, kidney failure, liver failure, hypertension, diabetes mellitus; Psychological disorder (mental illness, dementia, depression); HBs-Ag positive or HBc-Ab positive with HBV-DNA positive; HCV-Ab positive; HIV-Ab positive; Uncontrolled intercurrent infection; Other inadequate conditions determined by investigators; Hemoglobin < 10g/dL; Body Weight < 35kg; Splenomegaly; Uncontrolled severe complications; Porphyria; CNS involvement at screening; QTcF > 470ms at screening; Pregnant or nursing women; During participated in other clinical trials; In phase II part: subjects who registrated in phase I part of this trial.