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

NCT07075328 | Recruiting Phase 1 DMC

• 1 other identifier: PDT-21-001
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 5

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.

Conditions

Adult T-Cell Leukemia/Lymphoma (ATLL)

Outcome Measures

Primary Outcomes (2)

• Phase I part: Dose limiting toxicity

  Phase I part: 2 weeks

• Phase II part: Response rate (best overall response)

  Phase II part: 24 weeks

Study Arms (1)

OJP-001 Group

EXPERIMENTAL

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

Other: Drug:5-ALA, Device:Photodynamic system

Interventions

Drug:5-ALA, Device:Photodynamic system 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.

OJP-001 Group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Otsuka Medical Devices Co., Ltd. Japan: lead
• JIMRO Co., Ltd.: collaborator

Study Sites (5)

National Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

RECRUITING

Sapporo Hokuyu Hospital

Sapporo, Hokkaido, Japan

RECRUITING

Imamura general hospital

Kagoshima, Kagoshima-ken, Japan

RECRUITING

University of Miyazaki Hospital

Miyazaki, Miyazaki, Japan

RECRUITING

Nagasaki University Hospital

Nagasaki, Nagasaki, Japan

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Kentaro Ishinabe

CONTACT

+81363617459; OtsukaRegistry-CT@otsuka.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 20, 2025
• Study Start: April 1, 2024
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 29, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5)