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Phase 1 ST-001 nanoFenretinide for Relapsed/Refractory T-cell Lymphoma

This study is testing a new form of a drug called ST-001 nanoFenretinide for people with T-cell non-Hodgkin lymphoma that has come back or not responded to previous treatments (relapsed/refractory). This new form of the drug uses tiny particles (nanoparticle) to potentially reduce side effects seen with older versions of fenretinide. The study is looking to find the safest and highest dose of ST-001 nanoFenretinide. You may be able to join if you are 18 or older and have certain types of T-cell lymphomas, such as cutaneous T-cell lymphoma (CTCL) like mycosis fungoides (MF) or Sézary Syndrome (SS), or other specific non-cutaneous T-cell lymphomas. The study plans to enroll 46 participants, but its current status is unclear.

Study design
This is an interventional Phase 1 study, which means participants will receive the study drug. It will involve different groups of patients receiving increasing doses of ST-001 nanoFenretinide to find the maximum tolerated dose.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study, finding the maximum tolerated dose, will be measured at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04234048

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
SciTech Development, Inc.
~46 participants
Updated 2025-09-22 on ClinicalTrials.gov
What's tested:Fenretinide

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD)
Measured over 12 months

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

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Mature T-Cell and NK-Cell Non-Hodgkin LymphomaPrimary Cutaneous T-Cell Non-Hodgkin Lymphoma

NCT04234048

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Colorado Anschutz Medical Campus

    Aurora, Coloradostudy coordinator listed

    Recruiting

  • Barbara Ann Karmanos Cancer Institute Wayne State University

    Detroit, Michiganno site contact published

    Recruiting

  • City of Hope Medical Foundation

    Duarte, Californiano site contact published

    Recruiting

  • Columbia University

    New York, New Yorkno site contact published

    Recruiting

  • Mayo Clinic Arizona

    Scottsdale, Arizonano site contact published

    Recruiting

  • Northwestern University, Robert H. Lurie Comprehensive Cancer Center

    Chicago, Illinoisno site contact published

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texasno site contact published

    Recruiting

  • University of Michigan

    Ann Arbor, Michiganno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ali Moiin, MD · STUDY_DIRECTOR · SciTech Development, Inc.
  • Oleg E Akilov, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh Medical Center (UPMC)
  • Ann F Mohrbacher, MD · PRINCIPAL_INVESTIGATOR · University of Southern California
  • Barbara Pro, MD · PRINCIPAL_INVESTIGATOR · Columbia University
  • Dipenkumar Modi, MD · PRINCIPAL_INVESTIGATOR · Barbara Ann Karmanos Cancer Institute
  • Auris O Huen, MD, PharmD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
  • Ryan A Wilcox, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Michigan
  • Brad Haverkos, M.D. · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
  • Christiane Querfeld, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · City of Hope Medical Foundation
  • Aaron R Mangold, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic
  • Jonathan Moreira, M.D. · STUDY_DIRECTOR · Northwestern University, Robert H. Lurie Comprehensive Cancer Center

Who to contact

Louis M Scarmoutzos, PhD
[email protected]
(617) 283-2182
Email the study team

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Eligibility criteria

Inclusion

All patients must have histologically or cytologically confirmed diagnosis of the following specific types of T-cell lymphomas (TCL):
For standard phase 1a and expanded cohort (1b): Patients must all have at least one measurable disease site using criteria provided in section 11.
Relapsed or refractory (R/R) disease, after at least 1 prior treatment regimen as per disease staging (including but not limited to oral bexarotene, interferon, any oral or IV HDAC inhibitor, any topical, oral or IV chemotherapy drugs, radiotherapy, retinoids, topical steroids, systemic steroids, phototherapy, immunomodulators, Biologics and others based on PI discretion. Refer to section 2.1 of the protocol for more details).
Refractory disease is defined as lack of objective response (i.e., partial or complete response) to most recent therapy.
Relapsed disease is defined as recurrent disease after prior therapy that does not qualify as refractory disease.
Other systemic treatments not specified may be allowed based on PI judgement in consultation with the Sponsor.
For primary cutaneous lymphomas, stage IB, II, III and IV according to the TNMB system (Appendix C) are eligible. For primary nodal lymphomas, patients with stages II-IV according to the Ann Arbor staging system are eligible.
Minimum of 4 weeks must have elapsed since last systemic treatment or radiation therapy treatment (or 6 weeks for any nitrosourea-containing regimens), and patients must have recovered from all toxicity of last treatment. If the PI assesses that it is in the best interest of the patient to have a shorter washout period, they may submit a written request to the sponsor and can enroll the patient after written approval has been received.
Age ≥18 years. Both genders are included. However, women of childbearing potential must have a negative B-HCG serum pregnancy test (see Section 10 Study Calendar, Pre-Study, footnote b) and agree to use effective contraceptive methods for the duration of the study. A urine pregnancy test is required just prior to the first dosing session of every treatment cycle.
ECOG performance status 0-1 (Karnofsky ≥60%, see Appendix B).
Life expectancy greater than 6 months.
Patients must have normal organ and marrow function as defined below:
Leukocytes ≥ 3,000/μL
Absolute neutrophil count ≥ 1,500/μL
Platelets ≥ 100,000/μL
Total bilirubin within normal institutional limits. Patients with total bilirubin ≤ 1.5 X upper limit of normal are eligible
AST (SGOT) and ALT (SGPT) within institutional upper limit of normal
Creatinine clearance ≥60 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation
Absolute neutrophil count ≥ 500/μL
Platelets ≥ 50,000/μL
Triglyceride blood level (fasting) \<300mg/dL at time of enrollment (normal: \<150mg/dL; borderline high = 150-199mg/dL; high = 200-499mg/dL; very high = 500mg/dL or higher).
ST-001 is an experimental drug and the risks to the unborn or nursing child are unknown. Pregnant or breastfeeding women cannot take part in this study. Women of childbearing age are required to have a blood and/or urine pregnancy test before beginning the investigational study treatment. If you are sexually active, it is important that you not become pregnant or father a child because this medication may be harmful to your unborn child. Patients must discuss pregnancy plans with their doctor before enrolling in this study and agree that they will take the appropriate precautions not to become pregnant while enrolled in the study.

Exclusion

Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Patients who are receiving any other investigational agents.
Patients with known or history of central nervous system (CNS) disease are excluded from this clinical trial because of their poor prognosis and because of concerns regarding toxicity attribution.
History of allergic reactions or sensitivity to retinoids or to any excipients of ST-001.
Concomitant drug administration.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NY heart classification III/IV), unstable angina pectoris, cardiac arrhythmia, QTc interval \>450 milliseconds on baseline triplicate ECG, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because ST-001is a retinoid agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ST-001, breastfeeding should be discontinued if the mother is treated with ST-001.
HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ST-001. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Patients with any active hepatitis infections.
Presence of nyctalopia (night blindness), or hemeralopia (defective vision in a bright light, 'day blindness') at enrollment, or any other retinal, ophthalmological condition (eg: retinitis pigmentosa, choroidoretinitis and xerophthalmia), and glaucoma.
Patients who have received prior fenretinide systemic therapy
Patients with T-cell lymphoma types other than those specified in section 3.1.1 are not eligible even if they have cutaneous dissemination. Similarly, patients with any type of natural killer (NK)- or B-cell lymphoma are not eligible regardless of sites of involvement by disease.

What this trial measures

  • Maximum Tolerated Dose (MTD)12 months

    To determine the MTD of ST-001 nanoFenretinide (12.5mg/mL) for IV infusion in patients with CTCL and other T-cell NHL.