The Affiliated Hospital of Xuzhou Medical University
Phase
Not applicable
Started
2025-03-18
Last updated
2025-09-04
Condition(s) studied
Systemic Lupus ErythematosusSystemic Sclerosis
Investigational drug(s) / intervention(s)
UCAR-T cellsCyclophosphamideFludarabine
UCAR-T cells: UCAR-T cells will be administered intravenously as per the schedule specified in the protocol.
Cyclophosphamide: Cyclophosphamide will be administered intravenously.
Fludarabine: Fludarabine will be administered intravenously.
Study summary
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
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.
Exclusion Criteria:
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.
5. History of malignancy within five years.
Primary outcome measure(s)
To evaluate the safety and tolerability of UCAR T-cell in participants with relapse/ refractory autoimmune diseases — 2 years The incidence and severity of adverse events (AEs)
To evaluate the clinical responses and duration of UCAR-T cells in participants with relapse/ refractory autoimmune diseases — 2 years Proportion of participants achieving SRI-4 response, change in the Systemic Lupus Erythematosus Disease Activity Index(SLEDAI) from baseline
Trial sites (1)
Facility
City
Region
Status
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
China
More The Affiliated Hospital of Xuzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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