RecruitingAntineutrophil Cytoplasmic Antibody-associated Vasculitis
CC-97540 in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
The purpose of this study is to evaluate the safety of CC-97540 in relapsed or refractory severe antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
Sponsor: Marcela V. Maus, M.D.,Ph.D.
You may qualify if…
- ✓ Able to voluntarily provide written informed consent prior to the performance of any study-specific procedures.
- ✓ ≥18 years of age at the time of signing informed consent.
- ✓ 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.)
- ✓ Active ANCA-associated vasculitis within 6 weeks of screening presenting as either:
- ✓ 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
- ✓ Refractory disease (persistent BVASv3 positivity) despite standard-of-care treatment per the ACR/VF Guidelines (Chung et al., 2021). Refractory disease is defined as persistent BVASv3 positivity despite at least 6 weeks of appropriate guideline-indicated standard-of-care treatment per the ACR/VF Guidelines for the Management of ANCA-Associated Vasculitis.
- ✓ Appropriate guideline-indicated standard-of-care treatment per the ACR/VF Guidelines for the Management of ANCA-Associated Vasculitis includes:
You may not qualify if…
- ✕ 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.
- ✕ Prior organ transplant currently requiring an immunosuppressive regimen.
- ✕ Active malignancy requiring treatment other than non-metastatic basal cell or squamous cell skin carcinoma.
- ✕ Treatment with any prior CAR T cell therapy.
- ✕ Significant comorbid condition or disease which in the judgment of the Principal Investigator would place the subject at undue risk or interfere with the study.
Where it's recruiting
Massachusetts
Boston
Source: ClinicalTrials.gov · NCT07388277 · last updated 2026-05-15