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WITHDRAWN
NCT02943642
PHASE2

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

Sponsor: Virogen Biotechnology Inc.

View on ClinicalTrials.gov

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.

Official title: Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein (Resimmune®) in Subjects With Mycosis Fungoides: A Phase II Multi-center Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

0

Start Date

2026-05

Completion Date

2026-05-13

Last Updated

2026-05-18

Healthy Volunteers

No

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.