A Phase 1 study evaluating SC291, a hypoimmune, allogeneic CD19-directed CAR T cell therapy, in subjects with severe relapsed or refractory autoimmune diseases (GLEAM)

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Description

Screening and tapering of current immunosuppression therapy for up to 30 days; treatment with lymphodepleting therapy for 3 days followed by one treatment, via infusion, of SC291. Follow-up will be for at least one year.

Details
Age

Adult

Eligibility

Diagnosis of class III or IV lupus nephritis or ANCA-associated vasculitis or extrarenal lupus erythematosus that has relapsed following prior systemic treatmentLN subjects: Subjects diagnosed with SLE by 2019 EULAR/ACR Classification Criteria for SLE (Appendix 2) and having 2018 ISN/RPS Class III or IV biopsy-proven LN (concomitant Class V allowed) and relapsed with active lupus nephritis following �� 2 prior systemic treatment regimens (mycophenolate mofetil (MMF) or cyclophosphamide as first-line therapy for LN, followed by either rituximab, belimumab, voclosporin, or obinutuzumab as second-line therapy)... Subjects with active central nervous system (CNS) lupus or antiphospholipid antibody syndrome with a positive beta-2 glycoprotein-1 antibody test or a positive lupus anticoagulant assay will be excluded. ERL subjects: Subjects with a diagnosis of SLE according to 2019 EULAR/ACR Classification Criteria for SLE and with severe disease activity assessed SLEDAI-2K > 8. Subjects must be considered to have severe or relapsing disease not responding to at least 2 prior recent disease-modifying therapies such as MMF, azathioprine, cyclophosphamide, methotrexate, rituximab, belimumab, IVIg, abatacept, anifrolumab or other therapies, excluding glucocorticoids. Subjects with active CNS lupus or antiphospholipid antibody syndrome with a positive beta-2 glycoprotein-1 antibody test or a positive lupus anticoagulant assay will be excluded. AAV subjects: Subjects with either granulomatous polyangiitis or microscopic polyangiitis, defined by the 2022 ACR/EULAR classification criteria and confirmed to have severe AAV disease as defined by the presence of one or more major items BVAS v3. Subjects must have a diagnosis of a severe disease flare with BVAS v3 following the prior achievement of remission induced by a regimen consisting of anti-CD20 B cell depletion (e.g., rituximab or obinutuzumab) and glucocorticoids; cyclophosphamide and glucocorticoids; or anti-CD20 B cell depletion, cyclophosphamide and glucocorticoids. The flare must be considered organ or life-threatening. Subjects must be anti-proteinase 3 (PR3) autoantibody positive or anti-myeloperoxidase (MPO) autoantibody positive.

Locations

Outpatient CTRC
Renal Research Center
University of Colorado Hospital

Principal Investigator
Photograph of Amber Podoll

Amber Podoll

Study ID

Protocol Number: 23-2341

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