Engineered immune cells take on autoimmune diseases
NCT ID NCT07155369
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a new treatment for people with lupus or scleroderma that hasn't improved with standard care. The treatment uses specially engineered immune cells from a healthy donor (called universal CAR T-cells) to target and destroy faulty immune cells. The goal is to control the disease and reduce symptoms, not to cure it. The trial involves 18 participants and will monitor safety and effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- UCAR-T cells (universal donor CAR T-cells targeting CD19 and BCMA) with cyclophosphamide and fludarabine
- What this could lead to
- If successful, this could offer a new treatment option for people with severe lupus or scleroderma that hasn't responded to other therapies, potentially putting the disease into remission.
- What could go wrong
- This is a very early, small trial with only 18 participants, so results may not apply to everyone. CAR T-cell therapy can cause serious side effects like cytokine release syndrome and infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
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