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CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
Full description
This is an investigator-initiated trial to evaluate the safety and efficacy ofuniversal allogeneic anti-CD19/BCMA CAR T-cells in Patients With Relapse/Refractory Autoimmune Diseases.
Study intervention consists of a single infusion of universal allogeneic CART-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.
Interim analysis will be performed when participants finish the visit 12 and 24 weeks after CAR T-cell infusion.
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Inclusion criteria
Common Inclusion Criteria:
Disease-Specific Inclusion Criteria
Refractory/Relapsed SLE:
Refractory/Relapsed/Progressive Systemic Sclerosis:
Note: Meeting either criterion 4 or 5 is sufficient.
Refractory/Relapsed/Progressive Inflammatory Myopathy:
Note: Meeting either criterion 4 or 5 is sufficient.
Refractory/Relapsed ANCA-Associated Vasculitis:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
12 participants in 1 patient group
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Central trial contact
Ying Wang, PhD
Data sourced from clinicaltrials.gov
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