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

Prior treatment

• 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

Other illness

• Synchronous or metachronous malignancy
• 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
• Uncontrolled intercurrent infection
• Other inadequate conditions determined by investigators

Lab values

• Hemoglobin \< 10g/dL

Other

• Body Weight \< 35kg
• Splenomegaly
• Uncontrolled severe complications
• Porphyria
• CNS involvement at screening
• QTcF \> 470ms at screening
• Pregnant or nursing women
• During participated in other clinical trials
• In phase II part: subjects who registrated in phase I part of this trial

• 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