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RENEWAL: CD3/CD20 bispecific T-cell engager (CND261) in refractory ANCA-associated vasculitis
2025-522853-21-01Phase 2Authorised
- Sponsor
- Fraunhofer Institute for Translational Medicine and Pharmacology
- Start
- Jan 2026
- Modality
- T-cell Engagers → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics
- Countries
- 1
01
Overview
Phase 2, open-label, single-arm trial of CND261 in granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), sponsored by Fraunhofer Institute for Translational Medicine and Pharmacology. Primary endpoints: Incidence and severity of CRS, ICANS, and treatment-related AEs/SAEs (Phase I, safety), Safety and ANCA seroconversion rate (Phase II) and 2 more. Planned start Jan 2026; status: authorised.
02
Drugs
CND261
03
Conditions
granulomatosis with polyangiitis (GPA)microscopic polyangiitis (MPA)anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV)
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