RecruitingPhase 1NCT04234048

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


Sponsor

SciTech Development, Inc.

Enrollment

46 participants

Start Date

Dec 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new formulation of a drug called fenretinide (delivered as tiny particles called nanoparticles) in patients with relapsed or treatment-resistant T-cell lymphomas — a group of blood cancers involving T-cells of the immune system. **You may be eligible if...** - You have a confirmed diagnosis of a T-cell lymphoma (including cutaneous T-cell lymphoma such as mycosis fungoides, Sézary syndrome, or peripheral T-cell lymphoma) - Your lymphoma has come back or stopped responding to at least one prior treatment - You have at least one measurable site of disease - You are in reasonably good health and your organ function meets study requirements **You may NOT be eligible if...** - You have not received any prior treatment for your lymphoma - Your cancer is a different type of lymphoma not listed in the study - You have serious uncontrolled health conditions - You are pregnant or breastfeeding - You have significant organ dysfunction 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

DRUGFenretinide

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


Locations(10)

Mayo Clinic Arizona

Scottsdale, Arizona, United States

City of Hope Medical Foundation

Duarte, California, United States

University of Southern California

Los Angeles, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Northwestern University, Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, United States

University of Michigan

Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, Michigan, United States

Columbia University

New York, New York, United States

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04234048


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