Actively Recruiting
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
Led by Marcela V. Maus, M.D.,Ph.D. · Updated on 2026-05-15
12
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety and effectiveness of CC-97540, a CAR T cell therapy, in adults with relapsed or refractory antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, a condition that causes inflammation of blood vessels. This Phase I/II trial involves patients diagnosed with specific types of vasculitis and aims to learn if the investigational treatment can help manage this disease while assessing any risks. The U.S. Food and Drug Administration (FDA) has not yet approved CC-97540 for treating any condition. The study has two parts. In Part A, researchers will verify the safety of the treatment dose. In Part B, participants will receive CC-97540 CAR T cells at the confirmed dose. Before receiving CC-97540, patients undergo lymphodepleting chemotherapy using cyclophosphamide and fludarabine given intravenously. The CC-97540 treatment is given as a single intravenous infusion on day 0. Participants will be closely monitored from the day of infusion through up to 12 months afterward. Researchers will assess safety and treatment effects during this time, including tracking adverse events and measuring remission without additional treatment at 6 and 12 months. Participants will also have regular visits for tests, assessments, and follow-up to understand the treatment's impact and ensure safety throughout the study.
CONDITIONS
Brief Title
CC-97540 in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis
Who Can Participate
Eligibility Criteria
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).
- Current or past positive proteinase 3 (PR3) or myeloperoxidase (MPO) antibody test or ANCA immunofluorescence pattern.
- Active ANCA-associated vasculitis within 6 weeks of screening, either relapsed or refractory disease despite standard treatment.
- Severe or non-severe disease treated with appropriate standard-of-care therapies.
- Left ventricular ejection fraction greater than 45%.
- Adequate liver function with AST/ALT less than 2.5 times upper limit and bilirubin less than 1.5 times upper limit.
- Adequate kidney function with creatinine clearance over 30 ml/min.
- Absolute lymphocyte count of at least 300 cells/uL.
- Adequate hemoglobin and platelet counts.
- Willingness to follow contraceptive requirements for 12 months post-infusion.
- Ability and willingness to follow study visit schedule and protocol requirements.
You will not qualify if you...
- Positive 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 episode.
- Parkinson's disease, epilepsy, aphasia, or cerebellar disease.
- Prior organ transplant requiring immunosuppression.
- Active malignancy needing treatment except certain skin cancers.
- Prior CAR T cell therapy.
- Significant comorbidities posing risk or interfering with study.
- Active uncontrolled infections.
- History of severe heart failure or recent heart conditions.
- High bleeding risk or unstable coagulation.
- Low neutrophil count under 500 cells/uL.
- Symptomatic cerebrovascular or peripheral vascular disease requiring ongoing anticoagulation.
- Recent pulmonary embolism or deep vein thrombosis within 6 months.
- Pregnant or breastfeeding women.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - A few days prior to treatment infusion
Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine administered intravenously prior to the investigational treatment.
Several visits for chemotherapy infusions
Duration - Single day (Day 0)
Participants receive a single intravenous infusion of the investigational CC-97540 CAR T cell therapy on Day 0.
1 infusion visit (in-person)
Duration - Up to 12 months post-infusion
Participants are monitored for safety and efficacy outcomes for up to 12 months after the treatment infusion.
Regular follow-up visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
S
Sebastian Unizony, MD
K
Katherine Davis
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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