NCT04234048

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: SciTech Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates a fenretinide phospholipid suspension for the treatment of T-cell non-Hodgkin's lymphoma (NHL).

Detailed description

Fenretinide has been shown to be a relatively safe and effective anticancer therapy; however, dose limiting toxicities due to the excipients used in previous formulations has impeded its therapeutic utility. The product formulation in the current study (ST-001) is a phospholipid suspension of nanoparticle sized fenretinide. The current study is a Phase 1 trial in relapsed/refractory (R/R) T-cell non-Hodgkin's lymphoma in order to determine the safety profile, pharmacology, and maximum tolerated dose (MTD) of ST-001 nanoFenretinide. Targeted T-cell non-Hodgkin's lymphoma (T-Cell NHL) indications include: (1) Cutaneous T-cell lymphoma (CTCL) including mycosis fungoides (MF) and Sézary Syndrome (SS); (2) non-cutaneous T-cell lymphoma (non-CTCL) subtypes: angioimmunoblastic T-cell lymphoma (AITL), peripheral T-cell lymphoma (PTCL) not otherwise specified (NOS); and, follicular T-cell lymphoma (FTCL) as defined in the 2016 revision of the WHO classification of lymphoid malignancies.

Conditions

• T-cell Lymphoma
• Cutaneous/Peripheral T-Cell Lymphoma
• Peripheral T-cell Lymphoma
• Peripheral T-Cell Lymphoma, Not Classified
• Primary Cutaneous T-cell Lymphoma
• Cutaneous T-Cell Lymphoma, Unspecified
• Cutaneous T-cell Lymphoma
• Follicular T-Cell Lymphoma
• Angioimmunoblastic T-cell Lymphoma
• Sézary's Disease
• Mycosis Fungoides

Interventions

Type	Name	Description
DRUG	Fenretinide	Accelerated Phase 1a 100% Dose escalation in 8 single-patient cohorts Standard Phase 1a 40% Dose escalation in 3-patient cohorts X 3 cohorts Phase 1b Dosed at MTD in 20 patients as disease-specific expanded cohort

Timeline

• Start date: 2023-12-18
• Primary completion: 2026-12-01
• Completion: 2027-05-01
• First posted: 2020-01-21
• Last updated: 2025-09-22

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study