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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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