A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma

NCT ID: NCT07075328

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2028-08-31

Brief 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). 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.

Conditions

Adult T-Cell Leukemia/Lymphoma (ATLL)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OJP-001 Group

Patients will receive 5-ALA administered orally once. After administration of 5-ALA, patients will receive OJP-001 once.

Group Type: EXPERIMENTAL

Drug:5-ALA, Device:Photodynamic system

Intervention Type: OTHER

[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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JIMRO Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Otsuka Medical Devices Co., Ltd. Japan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sapporo Hokuyu Hospital

Sapporo, Hokkaido, Japan

Site Status: RECRUITING

Imamura general hospital

Kagoshima, Kagoshima-ken, Japan

Site Status: RECRUITING

National Kyushu Cancer Center

Fukuoka, , Japan

Site Status: RECRUITING

Nagasaki University Hospital

Nagasaki, , Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Kentaro Ishinabe

Role: CONTACT

OtsukaRegistry-CT@otsuka.jp

+81363617459

Facility Contacts

Kentaro Ishinabe

Role: primary

Kentaro Ishinabe

Role: primary

Kentaro Ishinabe

Role: primary

Kentaro Ishinabe

Role: primary

Other Identifiers

PDT-21-001

Identifier Type: -

Identifier Source: org_study_id