CC-97540 in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarcela V. Maus, M.D.,Ph.D.
About this trial
The purpose of this study is to evaluate the safety of CC-97540 in relapsed or refractory severe antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
Eligibility criteria
Qualifiers
Able to voluntarily provide written informed consent prior to the performance of any study-specific procedures.
Classification as granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) per the American College of Rheumatology (ACR) / European Alliance of Associations for Rheumatology (EULAR) 2022 definitions (Robson et al., 2022, Suppiah et al., 2022) (see Appendix A).
Current or historical positive proteinase 3 (PR3) or myeloperoxidase (MPO) antibody testing or a cytoplasmic (cANCA) or perinuclear antineutrophil cytoplasmic antibody (pANCA) immunofluorescence pattern. (Antibodies and immunofluorescence may currently be negative.)
Relapsed disease (BVASv3 > 0 following prior remission) despite standard-of-care treatment per the ACR/Vasculitis Foundation (VF) Guidelines for the Management of ANCA-Associated Vasculitis (Chung et al., 2021), or
Disqualifiers
Current or historical positivity for a glomerular basement membrane antibody.
ANCA-associated vasculitis deemed drug-induced or cocaine/levamisole-associated.
Treatment of relapsing disease with rituximab or other B cell-depleting therapy for the current episode of relapsed vasculitis. Prior rituximab use for a prior episode (flare) of vasculitis activity is permitted.
Parkinson's disease, epilepsy, aphasia, cerebellar disease.
Trial design
Treatments tested in this trial
- CC-97540
- Lymphodepletion Chemotherapy
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Marcela V. Maus, M.D.,Ph.D.
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov