drugset / Trial / NCT07529405
A Study of VG712 in Patients With Mycosis Fungoides
Phase 2
Not yet recruiting
386 enrolled
Virogen Biotechnology Inc.
H. Lee Moffitt Cancer Center and Research Institute · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
VG712 (A-dmDT390-bisFv(UCHT1) fusion protein) is a recombinant anti-CD3 immunotoxin that selectively depletes CD3-positive T cells through irreversible inhibition of protein synthesis. This Phase II study (CurbMF-001) evaluates the safety and efficacy of VG712 compared with mogamulizumab in subjects with relapsed or refractory mycosis fungoides (MF) who have failed 2 or more prior systemic therapies. The study has two parts: a lead-in dosing part (BOIN design, up to 24 subjects) to determine RP2D, followed by a randomized part (approximately 322 subjects, 1:1 VG712 vs. mogamulizumab). Sponsor: Virogen Biotechnology Inc.
Timeline
- Start
- 2026-07-30
- Primary completion
- 2030-12-30
- Completion
- 2032-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mogamulizumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | VG712 | Protein / enzyme biologic | 5 ug/kg | Intravenous |
| Subject | VG712 | Protein / enzyme biologic | 10 ug/kg | Intravenous |
| Subject | VG712 | Protein / enzyme biologic | 15 ug/kg | Intravenous |
| Subject | VG712 | Protein / enzyme biologic | 20 ug/kg | Intravenous |