A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma
Recruiting now · Phase 1/Phase 2
Conditions studied: Adult T-Cell Leukemia/Lymphoma (ATLL)
In brief
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.
Key facts
- Study ID
- NCT07075328
- Run by
- Otsuka Medical Devices Co., Ltd. Japan
- People needed
- 49
- Starts
- 2024-04-01
- Expected to finish
- 2028-08-31
- Last updated by the study team
- 2026-04-29
Who can join
Age: 20 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Body Weight < 35kg
- Hemoglobin < 10g/dL
- Splenomegaly
- 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 severe complications
- Porphyria
- 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
- CNS involvement at screening
- QTcF > 470ms at screening
- Uncontrolled intercurrent infection
- Pregnant or nursing women
- During participated in other clinical trials
Where it is running
- National Kyushu Cancer Center — Fukuoka, Fukuoka, Japan (enrolling)
- Sapporo Hokuyu Hospital — Sapporo, Hokkaido, Japan (enrolling)
- Imamura general hospital — Kagoshima, Kagoshima-ken, Japan (enrolling)
- University of Miyazaki Hospital — Miyazaki, Miyazaki, Japan (enrolling)
- Nagasaki University Hospital — Nagasaki, Nagasaki, Japan (enrolling)
Full record on ClinicalTrials.gov
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