OncoMatch/Clinical Trials/NCT07075328
A Phase I/II Study of OJP-001 in Patients With Adult T-cell Leukemia/Lymphoma
Is NCT07075328 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies non-drug interventions for adult t-cell leukemia/lymphoma (atll).
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: mogamulizumab (mogamulizumab)
Relapsed or recurrent ATL have history of treatment with mogamulizumab
Must have received: chemotherapy
At least one regimen of chemotherapy in case of intolerance/contraindication for mogamulizumab
Must have received: mogamulizumab (mogamulizumab)
Relapsed or recurrent ATL judged inadequate of treatment with mogamulizumab by investigators
Must have received: allogeneic hematopoietic stem cell transplantation
Relapsed or recurrent ATL after allogeneic hematopoietic stem cell transplantation
Cannot have received: chemotherapy
Chemotherapy or molecular-targeted agent for ATL : within 28 days prior to registration
Cannot have received: molecular-targeted agent
Chemotherapy or molecular-targeted agent for ATL : within 28 days prior to registration
Cannot have received: radiation therapy
Radiotherapy : within 28 days prior to registration
Cannot have received: investigational drug
Any investigational drugs or medical devices (unapproved in Japan) : within 28 days prior to registration
Cannot have received: autologous stem cell transplantation
Autologous stem cell transplantation : within 84 days prior to registration
Cannot have received: allogeneic stem cell transplantation
Allogenic stem cell transplantation : within 100 days prior to registration
Lab requirements
Blood counts
Hemoglobin >= 10g/dL
Liver function
T-Bil: =< ULNx2, AST and ALT: =< ULNx2.5
Cardiac function
Uncontrolled cardiac arrhythmia or Chronic congestive heart failure (NYHA Class III or IV) [excluded]; QTcF > 470ms at screening [excluded]
T-Bil: =< ULNx2, AST and ALT: =< ULNx2.5; Hemoglobin < 10g/dL [excluded]; Uncontrolled cardiac arrhythmia or Chronic congestive heart failure (NYHA Class III or IV) [excluded]; QTcF > 470ms at screening [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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