Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07388277

CC-97540 in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis

Led by Marcela V. Maus, M.D.,Ph.D. · Updated on 2026-05-11

12

Participants Needed

1

Research Sites

181 weeks

Total Duration

On this page

Sponsors

M

Marcela V. Maus, M.D.,Ph.D.

Lead Sponsor

B

Bristol-Myers Squibb

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the safety of CC-97540 in relapsed or refractory severe antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.

CONDITIONS

Official Title

CC-97540 in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to voluntarily provide written informed consent.
  • 18 years of age or older at consent.
  • Diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) as defined by ACR/EULAR 2022.
  • Current or past positive proteinase 3 (PR3) or myeloperoxidase (MPO) antibody test or specific ANCA immunofluorescence pattern.
  • Active ANCA-associated vasculitis within 6 weeks before screening, either relapsed or refractory despite standard-of-care treatment.
  • Severe disease as defined by specific clinical criteria or expert committee consensus.
  • Left ventricular ejection fraction greater than 45%.
  • Adequate liver function with AST/ALT less than 2.5 times upper limit of normal and bilirubin less than 1.5 times upper limit of normal.
  • Adequate kidney function with creatinine clearance over 30 ml/min.
  • Absolute lymphocyte count of at least 300 cells/uL.
  • Adequate organ function including hemoglobin at least 8 g/dL and platelet count at least 75,000/uL.
  • Willingness to follow contraceptive requirements during and after the study.
  • Ability and willingness to comply with study visits and protocol requirements.
Not Eligible

You will not qualify if you...

  • Current or past positivity for glomerular basement membrane antibody.
  • Drug-induced or cocaine/levamisole-associated ANCA vasculitis.
  • Treatment with rituximab or other B cell-depleting therapy for current relapse.
  • Parkinson's disease, epilepsy, aphasia, or cerebellar disease.
  • Prior organ transplant requiring immunosuppressive therapy.
  • Active cancer requiring treatment, except non-metastatic basal or squamous cell skin cancer.
  • Prior treatment with any CAR T cell therapy.
  • Significant other medical conditions posing risk or interfering with study.
  • Active uncontrolled bacterial, viral, or fungal infection.
  • History of severe heart failure or non-ischemic cardiomyopathy.
  • Recent unstable angina, heart attack, or ventricular arrhythmia.
  • High bleeding risk without stable anticoagulation.
  • Low absolute neutrophil count below 500 cells/uL.
  • Symptomatic cerebrovascular or peripheral vascular disease needing ongoing anticoagulation.
  • History of pulmonary embolism or deep vein thrombosis within 6 months requiring anticoagulation.
  • Pregnant or breastfeeding women.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

S

Sebastian Unizony, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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