Active — Not RecruitingNot Applicable

UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases

China18 participantsStarted 2025-03-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

To evaluate the safety and tolerability of UCAR T-cell in participants with relapse/ refractory autoimmune diseases

Timeframe: 2 years

To evaluate the clinical responses and duration of UCAR-T cells in participants with relapse/ refractory autoimmune diseases

Timeframe: 2 years

Trial details

NCT IDNCT07155369

SponsorThe Affiliated Hospital of Xuzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

View on ClinicalTrials.gov More Systemic Lupus Erythematosus trials