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Due to corporate strategic adjustment.
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This study is a single-arm, single-center Investigator-Initiated Trial (IIT) designed to evaluate the safety, pharmacokinetic profile, and preliminary efficacy of CD19-BCMA CAR-T cells in subjects diagnosed with connective tissue diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T | Experimental | The dosage range of 1.0 × 10^6/kg (± 20%) to 3.0 × 10^6/kg (± 20%) of CAR-T cells, administered intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR-T | Biological | Eligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Safety | Count the Incidence of adverse events | Up to 2 years after CAR-T infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness evaluation | The response rate of the responder index of systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), systemic sclerosis (scleroderma SSc), Sjogren's Syndrome, polymyositis/dermatomyositis, and mixed connective tissue disease (MCTD), as well as the changes in scores compared with the baseline value | Up to 2 years after CAR-T infusion |
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Inclusion Criteria:
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.
Previously diagnosed with one of the following diseases and meeting the corresponding latest international classification/diagnostic criteria :
Researchers determine that the disease is in an active stage;
At least one autoantibody is positive in the serum or plasma during the screening period;
Insufficient response, intolerance or recurrence to at least one standard treatment;
The pregnancy test of the female subjects was negative, and the subjects agreed to take effective contraceptive measures throughout the trial period.
The patient's major tissues and organs are functioning well.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuelin He, Ph.D. degree | Dongguan Taixin Hospital | Principal Investigator |
| Lan He, Ph.D. degree | Dongguan Taixin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguan Taixin Hospital | Dongguan | Guangdong | 523125 | China |
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| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| Pharmacokinetic parameters | The highest concentration of CAR-T cell expansion in peripheral blood after administration. | Up to 2 years after CAR-T infusion |
| Pharmacodynamic parameters | The peak values of CAR-T-related cytokines, which include at least IL-6 and IFN-γ. | Up to 2 years after CAR-T infusion |