RecruitingPhase 1Phase 2NCT05863234

Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia

Multicenter, Open-label, Dose-escalation Phase I/II Study to Evaluate the Tolerability, Safety, Efficacy and Pharmacokinetics of Repeated Continuous Intravenous PPMX-T003 in Patients With Aggressive NK Cell Leukaemia (ANKL) (Physician-initiated Clinical Trial)


Sponsor

Hiroshima University Hospital

Enrollment

7 participants

Start Date

Sep 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is Phase I/II Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This safety study looks at people with aggressive NK-cell leukemia (ANKL), a rare and serious blood cancer, who are not candidates for standard chemotherapy. The aim is to learn more about their disease course and explore alternative options. **You may be eligible if...** - You have been diagnosed with aggressive NK-cell leukemia (ANKL) — whether newly diagnosed or relapsed - You are not a candidate for standard chemotherapy **You may NOT be eligible if...** - You are eligible for and can receive standard chemotherapy as treatment for ANKL Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPPMX-T003

The therapeutic agent is administered continuously intravenously


Locations(1)

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

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NCT05863234


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