Evaluating the safety of PPMX-T003 for aggressive NK-cell leukemia
Official title: 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)
Run by Hiroshima University Hospital · NCT05863234 · Data updated 2026-11-12
This study is testing a new drug called PPMX-T003 to see if it is safe and effective for people with aggressive NK-cell leukemia.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 7 (estimated) |
| Sponsor | Hiroshima University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hiroshima, Hiroshima) |
| Status | Recruiting |
| Started | September 21, 2023 |
| Main results expected | March 31, 2026 |
| Study ends | March 31, 2026 |
| Registry record updated | April 30, 2025 |
| Trial ID | NCT05863234 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients diagnosed with aggressive NK-cell leukemia who are not eligible for chemotherapy.
✕Probably not a fit
Patients who are eligible to receive chemotherapy for their aggressive NK-cell leukemia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase I/II dose-escalation study designed to assess the tolerability, safety, efficacy, and pharmacokinetics of the investigational drug PPMX-T003 in patients with aggressive NK-cell leukemia. The study will include patients diagnosed with this condition, regardless of whether it is their first occurrence or a recurrence. The trial aims to gather data on how well the drug works and its safety profile in this specific patient population.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from aggressive NK-cell leukemia.
How similar studies have gone: While this approach is being evaluated in this specific context, similar studies have shown promise in treating other forms of leukemia with novel therapies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with ANKL (regardless of whether the disease is first or recurrent) based on diagnostic criteria developed with reference to the World Health Organization (WHO) 4th edition (2017) criteria. Exclusion Criteria: * Patients eligible to receive chemotherapy as treatment for ANKL
Where it's running
-
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan Recruiting
Study contacts
- Study coordinator: Kiyoshi Ando
- Email: andok@keyaki.cc.u-tokai.ac.jp
- Phone: +81 82-257-5555
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Epstein-Barr virus–positive T/NK-cell lymphoproliferative diseases in large patient groups
This study follows patients with EBV-positive T/NK-cell disorders to see how they present, what treatments are used, and how they respond over time.
-
Registry for individuals with T-cell lymphoma
This study is gathering information from people with T-cell lymphoma to help researchers learn more about the disease and improve treatments.
-
Evaluating DR-01 for treating specific types of lymphomas
This study is testing a new treatment called DR-01 to see if it can safely help adults with certain types of lymphomas feel better and fight their cancer.
-
Chemoimmunotherapy and stem cell transplant for NK T-cell leukemia and lymphoma
This study is testing two different treatment combinations for people with advanced NK-cell leukemia and lymphoma to see which one works better before they receive a stem cell transplant.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.