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

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.

Eligibility

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

Conditions2

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