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

Otsuka Medical Devices

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Adult T-Cell Leukemia/Lymphoma (ATLL)

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07075328

PDT-21-001

Details and patient eligibility

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.

Full 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.

Enrollment: 49 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

OJP-001 Group

Experimental group

Description:

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

Treatment:

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