CAR-T therapy for autoimmune diseases: study withdrawn before starting
NCT ID NCT07152223
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study planned to test a new cell therapy (CD19-BCMA CAR-T) for people with connective tissue diseases like lupus and rheumatoid arthritis. The goal was to see if it is safe and can control the disease. However, the study was withdrawn before enrolling any participants, so no results are available.
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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.
- Started
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Aug 2025
- Finished
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Mar 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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1 year to 70 years
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Good compliance: The patient or their guardian understands and voluntarily signs the informed consent form, and it is expected that all documents, procedures, follow-up examinations and treatments stipulated in the study can be completed. 2. Previously diagnosed with one of the following diseases and meeting the corresponding latest international classification/diagnostic criteria : 1. Systemic lupus erythematosus (SLE); 2. Rheumatoid arthritis (RA); 3. Systemic scleroderma (SSc) ; 4. Sjogren's Syndrome (SS); 5. Polymyositis/dermatomyositis (PM/DM); 6. Mixed connective tissue disease (MCTD). 3. Researchers determine that the disease is in an active stage; 4. At least one autoantibody is positive in the serum or plasma during the screening period; 5. Insufficient response, intolerance or recurrence to at least one standard treatment; 6. The pregnancy test of the female subjects was negative, and the subjects agreed to take effective contraceptive measures throughout the trial period. 7. The patient's major tissues and organs are functioning well. Exclusion Criteria: 1. Intracranial hypertension or confusion; 2. Symptomatic heart failure or severe arrhythmia; 3. Respiratory failure; 4. Accompanied by other types of malignant tumors; 5. Diffuse vascular coagulation; 6. Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value; 7. Sepsis or other difficult-to-control infections; 8. Uncontrollable diabetes; 9. Severe mental disorder; 10. Cranial magnetic resonance imaging (MRI) examination revealed obvious lesions in the intracranial cavity. 11. WHO physical status classification ≥ level 3; 12. Organ transplant recipients; 13. Pregnant and lactating women; 14. HIV+,HBV,HCV,EBV,CMV.
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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
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Dongguan Taixin Hospital
Dongguan, Guangdong, 523125, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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