Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein in Subjects With Mycosis Fungoides

Summary

This study evaluates the effectiveness - as judged by complete response - of a single four-day treatment with the fusion protein A-dmDT390-bisFv(UCHT1) compared to oral Zolinza (Vorinostat), in a randomized 2-arm trial after a maximum of 12 months of treatment. Patient eligibility is stage IB/IIB mycosis fungoides with mSWAT \< 50 who have never had lymphoid disease or a prior bone marrow / HSCT transplant.

Conditions

• Mycosis Fungoides

Interventions

BIOLOGICAL

A-dmDT390-bisFv(UCHT1)

anti-T cell immunotoxin (antibody targeting CD3 on T-cells tagged with diphtheria toxin without binding domain)

DRUG

Vorinostat

ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies.

Sponsors & Collaborators

• City of Hope National Medical Center

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Dana-Farber Cancer Institute

  collaborator OTHER

• Northwestern University Feinberg School of Medicine

  collaborator OTHER

• H. Lee Moffitt Cancer Center and Research Institute

  collaborator OTHER

• Ohio State University Comprehensive Cancer Center

  collaborator OTHER

• Rush University Medical Center

  collaborator OTHER

• Scott and White Hospital & Clinic

  collaborator OTHER

• Yale University

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• University of Arkansas

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Vanderbilt University School of Medicine

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Virogen Biotechnology Inc.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-31

Primary Completion

2026-05-13

Completion

2026-05-13

FDA Drug

Yes