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New treatment option for Antineutrophil Cytoplasmic Antibody-associated Vasculitis
Official title CC-97540 in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis
ClinicalTrials.gov ID: NCT07388277
What this study is testing
What is CC-97540?
CC-97540 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for antineutrophil cytoplasmic antibody-associated vasculitis.
Also referred to as BMS-986353, CD19-Targeted NEX-T CAR T Cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety of CC-97540 in relapsed or refractory severe antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Able to voluntarily provide written informed consent prior to the performance of any study-specific procedures. -≥18 years of age at the time of...
- Classification as granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) per the American College of Rheumatology (ACR) / European...
- Current or historical positive proteinase 3 (PR3) or myeloperoxidase (MPO) antibody testing or a cytoplasmic (cANCA) or perinuclear antineutrophil...
- Active ANCA-associated vasculitis within 6 weeks of screening presenting as either:
- Relapsed disease (BVASv3 \> 0 following prior remission) despite standard-of-care treatment per the ACR/Vasculitis Foundation (VF) Guidelines for the...
You likely can't join if
- 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...
- Parkinson's disease, epilepsy, aphasia, cerebellar disease.
- Prior organ transplant currently requiring an immunosuppressive regimen.
- Active malignancy requiring treatment other than non-metastatic basal cell or squamous cell skin carcinoma.
See the full eligibility criteria
- Able to voluntarily provide written informed consent prior to the performance of any study-specific procedures. -≥18 years of age at the time of signing informed consent.
- 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...
- 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...
- Active ANCA-associated vasculitis within 6 weeks of screening presenting as either:
- 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
- Refractory disease (persistent BVASv3 positivity) despite standard-of-care treatment per the ACR/VF Guidelines (Chung et al., 2021). Refractory disease is defined as persistent BVASv3 positivity despite at least 6 weeks...
- either rituximab or cyclophosphamide for severe disease;
- or, methotrexate or azathioprine for non-severe disease. -Severe disease activity defined as:
- 1 or more major BVAS/WG criteria or at least 3 minor BVASv3 items (see Appendix B), or
- 1 or more of cutaneous ulceration, retroorbital disease, sinonasal disease with bony or cartilage damage, subglottic stenosis, or renal involvement, or
- Unanimous expert committee consensus on severity (3/3 agreement).
- Left ventricular ejection fraction \> 45%.
- Adequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \<2.5 × upper limit of normal (ULN) and direct bilirubin \<1.5 × ULN. Elevation in bilirubin attributable to...
- Adequate renal function defined by creatinine clearance \>30 ml/min using the Cockcroft-Gault formula. Measured creatinine clearance from a 24-hour urine collection is acceptable if clinically indicated. For select...
- Absolute lymphocyte count of ≥ 300 cells/uL.
- Adequate organ function defined as:
- Hemoglobin ≥ 8 g/dL
- Platelet count ≥ 75,000/uL
- Willingness to adhere to contraceptive requirements. The effects of CC-97540 CAR T cells on the developing human fetus are unknown. Lymphodepleting chemotherapy poses genotoxic, fetotoxic, and infertility risks. For...
- Ability and willingness to adhere to the study visit schedule and all protocol requirements.
- 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.
- Prior organ transplant currently requiring an immunosuppressive regimen.
- Active malignancy requiring treatment other than non-metastatic basal cell or squamous cell skin carcinoma.
- Treatment with any prior CAR T cell therapy.
- Significant comorbid condition or disease which in the judgment of the Principal Investigator would place the subject at undue risk or interfere with the study.
- Active, uncontrolled, systemic bacterial, viral, or fungal infection.
- people with a history of class III or IV congestive heart failure or with a history of non- ischemic cardiomyopathy.
- people with unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the previous 3 months.
- people with high bleeding risk including INR or PTT greater than 1.5 times the upper limit of normal unless due to a stable dose of anticoagulation. Ongoing anticoagulation permitted if a stable regimen.
- Absolute neutrophil count \< 500 cells/uL.
- Symptomatic cerebrovascular disease or peripheral vascular arterial disease requiring ongoing therapeutic anticoagulation or dual antiplatelet therapy or other vascular disease not allowing for holding of DAPT.
- people with a history of pulmonary embolism (PE) or deep vein thrombosis (DVT) within 6 months of beginning lymphodepletion requiring ongoing anticoagulation.
- Pregnant or lactating women. Pregnant women are excluded from this study because CC-97540 CAR T cell drug products are agents with the potential for adverse effects for a fetus. Because there is an unknown but potential...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.