NCT07388277

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

A Phase I/II Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Marcela V. Maus, M.D.,Ph.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a two-part, non-randomized, open label, single site Phase I/II study to assess the safety and efficacy of CC-97540 CAR T cell products for treatment of relapsing or refractory ANCA-associated vasculitis. This study consists of 2 parts: Part A (Safety Lead-In), a verification of the safety of the infusion dose, and Part B (Expansion), in which participants receive CC-97540 CAR T cells at the dose confirmed in Part A. This is a Phase I/II clinical trial. Phase I/II clinical trials test the safety and effectiveness of an investigational therapy to learn whether the therapy works in treating a specific disease. "Investigational" means that the therapy is being studied. The U.S. Food and Drug Administration (FDA) has not approved CC-97540 as a treatment for any disease. It is expected that about 12 people will take part in this research study.

Conditions

• Antineutrophil Cytoplasmic Antibody-associated Vasculitis

Interventions

Type	Name	Description
DRUG	CC-97540	Intravenous infusion
DRUG	Lymphodepletion Chemotherapy	Intravenous infusion of cyclophosphamide and fludarabine

Timeline

• Start date: 2026-07-09
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2026-02-05
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study