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 (Jun 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)
Demographics
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.
Frequently asked questions
Is NCT07075328 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, molecular-targeted agent, radiation therapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 85 years or younger and at least 20 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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