Phase 1a1b Study of ST-001 nanoFenretinide for Relapsed or Refractory T-cell Non-Hodgkin Lymphoma Evaluating Safety, Dose, and Pharmacology by Intravenous Infusion

What this Trial Is About

Researchers are evaluating a new formulation of fenretinide, called ST-001 nanoFenretinide, for treating relapsed or refractory T-cell non-Hodgkins lymphoma NHL. This Phase 1 trial focuses on determining the safety, how the drug moves through the body, and the highest dose patients can tolerate. The study targets specific T-cell lymphomas, including cutaneous types like mycosis fungoides and Szary Syndrome, as well as nodal types such as peripheral T-cell lymphoma and angioimmunoblastic T-cell lymphoma, based on the 2016 WHO classification. Participants receive ST-001 nanoFenretinide intravenously as a phospholipid suspension of nanoparticle-sized fenretinide. The trial includes three parts an accelerated Phase 1a with single-patient dose escalations across nine levels, a standard Phase 1a with 3-patient cohorts escalating through four higher dose levels, and a Phase 1b where 20 patients receive the maximum tolerated dose identified. Each dose is given for 5 days every 21 days. Throughout the study, patients undergo regular assessments to monitor safety, drug levels, and immune cell activation. Researchers also track responses to treatment, including complete or partial lymphoma remission. The main outcome is the maximum tolerated dose over 12 months, with safety and immune response evaluated up to 24 months. Participants are closely monitored with blood tests, imaging, and questionnaires during treatment and follow-up periods.

Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma