drugset / Trial / NCT02943642
Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein in Subjects With Mycosis Fungoides
Phase 2
Withdrawn
Virogen Biotechnology Inc.
City of Hope National Medical Center · collabColumbia University · collabDana-Farber Cancer Institute · collabH. Lee Moffitt Cancer Center and Research Institute · collabNorthwestern University · collabOhio State University Comprehensive Cancer Center · collabRush University Medical Center · collabScott and White Hospital & Clinic · collabStanford University · collabThomas Jefferson University · collabUniversity of Arkansas · collabUniversity of Colorado, Denver · collabUniversity of Texas Southwestern Medical Center · collabUniversity of Washington · collabVanderbilt University School of Medicine · collabWashington University School of Medicine · collabYale University · collab
RandomizedCrossoverOpen-labelTreatment
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.
Timeline
- Start
- 2026-05
- Primary completion
- 2026-05-13
- Completion
- 2026-05-13
Outcome
Outcome not reported
Stopped: “This record is an earlier version (crossover design). After FDA-approved IND sponsor transfer to Virogen, the study was redesigned. This protocol will never start. The new protocol is NCT07529405.”
Publications
- Results Frankel AE, Woo JH, Ahn C, Foss FM, Duvic M, Neville PH, Neville DM. Resimmune, an anti-CD3epsilon recombinant immunotoxin, induces durable remissions in patients with cutaneous T-cell lymphoma. Haematologica. 2015 Jun;100(6):794-800. doi: 10.3324/haematol.2015.123711. Epub 2015 Mar 20.
- Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Resimmune® | Protein / enzyme biologic | 5 ug/kg | Intravenous |
| Subject | Resimmune® | Protein / enzyme biologic | 10 ug/kg | Intravenous |
| Comparator | Vorinostat | Small molecule | 400 mg | Oral |