Adult T-Cell Leukemia/Lymphoma (ATLL)Phase 1/2NCT07075328
A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma
A Phase 1/2 study testing Drug:5-ALA, Device:Photodynamic system in people with Adult T-Cell Leukemia/Lymphoma (ATLL), run by Otsuka Medical Devices Co., Ltd. Japan at 5 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Adult T-Cell Leukemia/Lymphoma (ATLL)
- What is being tested?
- Drug:5-ALA, Device:Photodynamic system
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 5 sitesJapan
- Study dates
- 1 Apr 2024to 31 Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Japan5 sites, 5 recruiting
- Recruiting
National Kyushu Cancer Center
Fukuoka, Fukuoka
Kentaro Ishinabe
- Recruiting
Imamura general hospital
Kagoshima, Kagoshima-ken
Kentaro Ishinabe
- Recruiting
University of Miyazaki Hospital
Miyazaki, Miyazaki
Kentaro Ishinabe
- Recruiting
Nagasaki University Hospital
Nagasaki, Nagasaki
Kentaro Ishinabe
- Recruiting
Sapporo Hokuyu Hospital
Sapporo, Hokkaido
Kentaro Ishinabe
About this study
Official title: 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.
Read the detailed description
[Phase I part] Patients will receive 5-ALA administered orally once. After administration of 5-ALA, patients will receive OJP-001 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 OJP-001 once a week for 6 months.
- Conditions
- Adult T-Cell Leukemia/Lymphoma (ATLL)
- Being tested
- Drug:5-ALA, Device:Photodynamic system
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug:5-ALA, Device:Photodynamic systemOther
[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.
| Study group | Role | What they receive |
|---|---|---|
| OJP-001 Group | Experimental | Patients will receive 5-ALA administered orally once. After administration of 5-ALA, patients will receive OJP-001 once. Receives: Other: Drug:5-ALA, Device:Photodynamic system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I part: Dose limiting toxicity
Measured: Phase I part: 2 weeks
Phase II part: Response rate (best overall response)
Measured: Phase II part: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Apr 2024
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult T-Cell Leukemia/Lymphoma (ATLL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Medical Devices Co., Ltd. Japan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JIMRO Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075328
- Sponsor's protocol ID
- PDT-21-001
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of OJP-001 for Recurrent or Relapsed Adult T-cell Leukemia/Lymphoma Patients With Peripheral Blood Tumor.
- ClinicalTrials.gov ID
- NCT07075328
- Acronym / sponsor ID
- PDT-21-001
- Conditions
- Adult T-Cell Leukemia/Lymphoma (ATLL)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Otsuka Medical Devices Co., Ltd. JapanIndustry (pharma, biotech, devices)
- Collaborators
- JIMRO Co., Ltd.
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
[Phase I part] Patients will receive 5-ALA administered orally once. After administration of 5-ALA, patients will receive OJP-001 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 OJP-001 once a week for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OJP-001 Group | Experimental | Other: Drug:5-ALA, Device:Photodynamic systemPatients will receive 5-ALA administered orally once. After administration of 5-ALA, patients will receive OJP-001 once. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- Having peripheral blood lesion
- ECOG performance status: 0-2
Key exclusion criteria (27 listed)
- Body Weight < 35kg
- Hemoglobin < 10g/dL
- Splenomegaly
- Subjects who received an following therapy
- Administrated 5-ALA drug except study drug within 7 days prior to registration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug:5-ALA, Device:Photodynamic system[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. | Other | OJP-001 Group |
Primary outcome
Phase I part: Dose limiting toxicity
Time frame: Phase I part: 2 weeks
Phase II part: Response rate (best overall response)
Time frame: Phase II part: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Adult T-Cell Leukemia/Lymphoma (ATLL)
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
Not yet recruitingPhase 1
Universal 4SCAR7U Targeting CD7-positive Malignancies
T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma
Not yet recruitingPhase 1/2
Multi-CAR T Cell Therapy Targeting CD7-positive Malignancies
T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma
RecruitingPhase 1
Testing the Addition of an Anti-cancer Drug, Lenalidomide, to the Usual Combination Chemotherapy Treatment ("EPOCH") for Adult T-Cell Leukemia-Lymphoma (ATLL)
Acute Adult T-Cell Leukemia/Lymphoma, Adult T-Cell Leukemia/Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Drug:5-ALA, Device:Photodynamic system in people with Adult T-Cell Leukemia/Lymphoma (ATLL), run by Otsuka Medical Devices Co., Ltd. Japan at 5 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kentaro Ishinabe (+81363617459, OtsukaRegistry-CT@otsuka.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I part: Dose limiting toxicity (time frame: Phase I part: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.