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

NCT04234048 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-09-22

No results posted yet for this study

Summary

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

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

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

Sponsors & Collaborators

  • SciTech Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Ali Moiin, MD · SciTech Development, Inc.

  • Oleg E Akilov, MD, PhD · University of Pittsburgh Medical Center (UPMC)

  • Ann F Mohrbacher, MD · University of Southern California

  • Barbara Pro, MD · Columbia University

  • Dipenkumar Modi, MD · Barbara Ann Karmanos Cancer Institute

  • Auris O Huen, MD, PharmD · M.D. Anderson Cancer Center

  • Ryan A Wilcox, MD, PhD · University of Michigan

  • Brad Haverkos, M.D. · University of Colorado, Denver

  • Christiane Querfeld, M.D., Ph.D. · City of Hope Medical Foundation

  • Aaron R Mangold, M.D. · Mayo Clinic

  • Jonathan Moreira, M.D. · Northwestern University, Robert H. Lurie Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-18
Primary Completion
2026-12-01
Completion
2027-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04234048 on ClinicalTrials.gov