Status:
ACTIVE_NOT_RECRUITING
UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases
Lead Sponsor:
The Affiliated Hospital of Xuzhou Medical University
Collaborating Sponsors:
Shanghai Xiniao Biotech Co., Ltd.
Conditions:
Systemic Lupus Erythematosus
Systemic Sclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed 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 interventi...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old (inclusive), regardless of gender.
- Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.
- Adequate hepatic, renal and bone marrow function.
- Participants with relapsed or refractory autoimmune diseases, Including SLE or SSc.
Exclusion
- Participants with a history of severe drug allergies or allergic constitutions.
- Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.
- Participants with insufficient cardiac function.
- Participants with congenital immunoglobulin deficiencies.
- History of malignancy within five years.
Key Trial Info
Start Date :
March 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT07155369
Start Date
March 18 2025
End Date
September 1 2028
Last Update
September 4 2025
Active Locations (1)
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1
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China