Actively Recruiting
Phase 1a/1b Trial to Evaluate Safety, Pharmacology, and Maximum Tolerated Dose of ST-001 NanoFenretinide for Relapsed/Refractory T-cell Non-Hodgkin Lymphoma
Led by SciTech Development, Inc. · Updated on 2025-09-22
46
Participants Needed
10
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
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-Hodgkin's 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 Sézary 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.
CONDITIONS
Brief Title
Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of specific T-cell lymphomas: cutaneous T-cell lymphoma (mycosis fungoides, Sézary Syndrome, or primary cutaneous CD30+ anaplastic large cell lymphoma) or nodal T-cell lymphoma (peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, or follicular T-cell lymphoma) confirmed by biopsy
- Relapsed or refractory disease after at least one prior treatment regimen
- At least one measurable disease site (for standard phase 1a and phase 1b participants)
- Minimum of 4 weeks since last systemic treatment or radiation therapy (6 weeks for nitrosourea-containing regimens), with recovery from treatment toxicities
- ECOG performance status of 0 or 1 and life expectancy greater than 6 months
- Normal organ and marrow function as specified in the protocol
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 4 months after last dose
- Ability to provide informed consent or have a legal representative consent
You will not qualify if you...
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) before study entry or not recovered from prior treatment adverse events
- Concurrent use of other investigational agents
- Known or history of central nervous system disease
- Allergy or sensitivity to retinoids or excipients of ST-001
- Concurrent treatment with strong CYP3A inducers or inhibitors, or recent use within 4 weeks
- Use of vitamin A supplements (standard multivitamins allowed)
- Uncontrolled illness including active infection, severe heart failure, unstable angina, arrhythmia, prolonged QTc interval, or psychiatric/social issues limiting compliance
- Pregnancy or breastfeeding
- HIV-positive patients on combination antiretroviral therapy
- Active hepatitis infections
- Presence of night blindness, defective vision in bright light, retinal or ophthalmological conditions, or glaucoma
- Prior systemic fenretinide therapy
- T-cell lymphoma types not specified in inclusion criteria or any natural killer (NK) or B-cell lymphoma types regardless of disease sites
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles; dosing is 5 days per cycle; duration depends on dose escalation and cohort phase
Participants receive ST-001 nanoFenretinide in dose-escalation cohorts or at the maximum tolerated dose to evaluate safety and pharmacology.
Multiple visits every 21 days during dosing cycles
Trial Site Locations
Total: 10 locations
1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
City of Hope Medical Foundation
Duarte, California, United States, 91010
Actively Recruiting
3
University of Southern California
Los Angeles, California, United States, 90007
Actively Recruiting
4
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Northwestern University, Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611
Actively Recruiting
6
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
7
Barbara Ann Karmanos Cancer Institute Wayne State University
Detroit, Michigan, United States, 48201
Actively Recruiting
8
Columbia University
New York, New York, United States, 10032
Actively Recruiting
9
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15219
Actively Recruiting
10
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
L
Louis M Scarmoutzos, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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