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](https://som.ucdenver.edu/FIMS/Content/faculty/28666/CU-Doctors-28666.jpg)
Amber Podoll
Study ID
Protocol Number: 23-2341
Categories
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