New light therapy targets hard-to-treat blood cancer
NCT ID NCT07075328
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment called OJP-001 for people with adult T-cell leukemia/lymphoma (ATLL) that has come back after prior therapy. The treatment uses a light-sensitive drug and a machine to treat the blood outside the body, aiming to kill cancer cells. The study will check safety, find the best dose, and see how well it works in up to 49 participants aged 20 to 85.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 49 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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 * Other inadequate conditions determined by investigators * In phase II part: subjects who registrated in phase I part of this trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Imamura general hospital
RECRUITINGKagoshima, Kagoshima-ken, Japan
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Nagasaki University Hospital
RECRUITINGNagasaki, Nagasaki, Japan
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National Kyushu Cancer Center
RECRUITINGFukuoka, Fukuoka, Japan
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Sapporo Hokuyu Hospital
RECRUITINGSapporo, Hokkaido, Japan
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University of Miyazaki Hospital
RECRUITINGMiyazaki, Miyazaki, Japan