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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CC-97540
DrugIntravenous infusion
Lymphodepletion Chemotherapy
DrugIntravenous infusion of cyclophosphamide and fludarabine
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: CC-97540Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Safety of CC-97540 in ANCA-Associated Vasculitis
The occurrence of DLT is the primary endpoint and will be assessed for all patients treated at the expansion dose.
Time frame
Study drug infusion (day 0) to 28 days post study drug infusion, assessed up to 12 months post study drug infusion.2
Efficacy of CC-97540
This will be determined by the percentage of participants in treatment-free remission defined as a BVASv3 of 0 off immunosuppressive therapy.
Time frame
Study drug infusion (day 0) to 28 days post study drug infusion, assessed up to 12 months post study drug infusion.Secondary outcomes
1
Number of Adverse Events
Adverse events will be classified and graded according to the CTCAE v.5.0. This will be determined by the proportion of participants experiencing treatment-related serious AEs.
Time frame
Study drug infusion (day 0) to 28 days post study drug infusion, assessed up to 12 months post study drug infusion.2
6 Months Treatment-Free Remission
Determined by the percentage of participants in treatment-free remission.
Time frame
Study drug infusion (day 0) to 28 days post study drug infusion, assessed up to 6-months following study drug infusion.3
6 Months Sustained Treatment-Free Remission
Determined by the percentage of participants in sustained treatment-free remission BVASv3 of 0 without use of immunosuppressive therapy since CAR T cell infusion.
Time frame
Study drug infusion (day 0) to 28 days post study drug infusion, assessed up to 6-months following study drug infusion.4
12 Months Sustained Treatment-Free Remission
Determined by the percentage of participants in sustained treatment-free remission at 12 months following infusion of CC-97540.
Time frame
Study drug infusion (day 0) to 28 days post study drug infusion, assessed up to 12 months post study drug infusion.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Marcela V. Maus, M.D.,Ph.D.
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov