Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The Affiliated Hospital of Xuzhou Medical University
With
Shanghai Xiniao Biotech Co., Ltd.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Age ≥ 18 years old (inclusive), regardless of gender.
2. Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.
3. Adequate hepatic, renal and bone marrow function.
4. Participants with relapsed or refractory autoimmune diseases, Including SLE or SSc.
You may not be if
1. Participants with a history of severe drug allergies or allergic constitutions.
2. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.
3. Participants with insufficient cardiac function.
4. Participants with congenital immunoglobulin deficiencies.
