Status and phase
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About
A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects with Systemic Sclerosis
Full description
SSc is an immune-mediated rheumatic disease that is characterized by fibrosis of the skin and internal organs and vasculopathy. B-cells play a role in SSc, and the disease is characterized by the presence of autoantibodies such as anti-Scl-70 and anti-RNAP III antibodies. CD19-targeted chimeric antigen receptor (CAR) T-cells harness the ability of cytotoxic T-cells to directly and specifically lyse target cells to effectively deplete B-cells in the circulation and in lymphoid and potentially non-lymphoid tissues. KYV-101, a fully human anti-CD19 CAR T-cell therapy, will be investigated in adult subjects with systemic sclerosis.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria
Key Exclusion Criteria
Clinically significant ILD
Prior treatment with cellular therapy (CAR-T) or gene therapy product directed at any target
History of allogeneic or autologous stem cell transplant
Evidence of active hepatitis B or hepatitis C infection
Positive serology for HIV
Primary immunodeficiency
History of splenectomy
History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder investigator considers would increase the risk for the subject
Impaired cardiac function or clinically significant cardiac disease
Previous or concurrent malignancy with the following exceptions:
Primary purpose
Allocation
Interventional model
Masking
21 participants in 2 patient groups
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Central trial contact
Kyverna Therapeutics, Inc.
Data sourced from clinicaltrials.gov
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