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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Marcela V. Maus, M.D.,Ph.D.
Study ID
NCT07388277
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Antineutrophil Cytoplasmic Antibody-associated Vasculitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CC-97540 — DRUG
    Intravenous infusion
  • Lymphodepletion Chemotherapy — DRUG
    Intravenous infusion of cyclophosphamide and fludarabine

Study Details

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

Key Dates

Start date
Jul 9, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CC-97540
    Prior to receiving CC-97540, participants will undergo lymphodepleting chemotherapy. Lymphodepleting chemotherapy is the combination of cyclophosphamide and fludarabine and will be administered intravenously. CC-97540 will be infused intravenously on day 0 only.

Primary Outcome Measure

Safety of CC-97540 in ANCA-Associated Vasculitis [ Time Frame: Study drug infusion (day 0) to 28 days post study drug infusion, assessed up to 12 months post study drug infusion. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Sebastian Unizony, MD
[email protected]
617-726-2000
Sebastian Unizony, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

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