A Phase 1a/1b Trial in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a fenretinide phospholipid suspension (12.5 mg/mL) for Intravenous Infusion

The purpose of this study is to see what effects, good and/or bad, the study drug, ST-001, has on you and your cancer, to find the best dose for treating your condition, and to see how safe ST-001 is for participants with your condition. This study will help us understand more about whether intravenous (injected into the vein) ST-001, will be a useful study treatment for subjects with Relapsed/Refractory T-cell Non-Hodgkin Lymphoma (T-Cell NHL). Relapsed or refractory disease means your disease that has come back after initial treatment or did not respond to initial treatment. Approximately 46 patients will be enrolled across 5-10 clinical sites nationwide. ST-001 has not been studied in human clinical trials yet.

Are you Eligible? (Inclusion Criteria)

• Age ≥18 years. Both genders are included. - Relapsed or refractory (R/R) disease, after at least 2 prior systemic drug treatment regimens - willing to come to the clinic for additional evaluations and treatments