Actively Recruiting
A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma
Led by Otsuka Medical Devices Co., Ltd. Japan · Updated on 2026-04-29
49
Participants Needed
5
Research Sites
230 weeks
Total Duration
On this page
Sponsors
O
Otsuka Medical Devices Co., Ltd. Japan
Lead Sponsor
J
JIMRO Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hematocytologically or pathohistologically confirmed adult T-cell leukemia/lymphoma with positive anti-HTLV-1 antibody (aggressive subtypes: acute, lymphoma type, or chronic type with unfavorable factor)
- Age between 20 and 85 years
- Meet at least one of the following for screening: relapsed or recurrent ATL with prior mogamulizumab treatment; or intolerance/contraindication to mogamulizumab with at least one chemotherapy regimen; or judged inappropriate for mogamulizumab; or relapsed/recurrent ATL after allogeneic hematopoietic stem cell transplantation
- Presence of peripheral blood lesion
- ECOG performance status of 0 to 2
- Total bilirubin less than or equal to twice the upper limit of normal, AST and ALT less than or equal to 2.5 times the upper limit of normal
- Expected survival of more than 3 months
You will not qualify if you...
- Body weight less than 35 kg
- Hemoglobin less than 10 g/dL
- Presence of splenomegaly
- Received chemotherapy or molecular-targeted agent for ATL within 28 days prior to registration
- Received radiotherapy within 28 days prior to registration
- Received investigational drugs or unapproved medical devices within 28 days prior to registration
- Received autologous stem cell transplantation within 84 days prior to registration
- Received allogeneic stem cell transplantation within 100 days prior to registration
- Received 5-ALA drug other than study drug within 7 days prior to registration
- Consumed foods containing 5-ALA or St. John's wort within 7 days prior to registration
- Presence of 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 disorders including mental illness, dementia, or depression
- Positive for HBs-Ag or HBc-Ab with HBV-DNA positive
- Positive for HCV antibody
- Positive for HIV antibody
- Central nervous system involvement at screening
- QTcF greater than 470 ms at screening
- Uncontrolled intercurrent infection
- Pregnant or nursing women
- Participation in other clinical trials
- Other conditions deemed inadequate by investigators
- In Phase II, prior participation in Phase I part of this trial
AI-Screening
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Trial Site Locations
Total: 5 locations
1
National Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
Actively Recruiting
2
Sapporo Hokuyu Hospital
Sapporo, Hokkaido, Japan
Actively Recruiting
3
Imamura general hospital
Kagoshima, Kagoshima-ken, Japan
Actively Recruiting
4
University of Miyazaki Hospital
Miyazaki, Miyazaki, Japan
Actively Recruiting
5
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan
Actively Recruiting
Research Team
K
Kentaro Ishinabe
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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