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This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with active SLE, SSc, AAV, IIM, NMOSD, MS, MG
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RD06-05 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RD06-05 CART Cell Injection | Drug | CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESI) during treatment | 2 Years |
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Inclusion Criteria:
The subjects voluntarily participated in the study and signed the informed consent form.
Age ≥18 years old and ≤70 years old, both sexes.
Organ function and laboratory tests:
Negative serum or urine pregnancy test results in female subjects of childbearing potential at screening.
Women of childbearing potential must agree to use a highly effective method of contraception for at least 28 days before initiation of elution and up to 12 months after RD06-04 reinfusion. Men of childbearing potential had to agree to the use of an effective barrier method of contraception from the initiation of lymphoidectomy until 12 months after reinfusion of RD06-04 and had to refrain from donating semen or sperm throughout the trial.
SLE Patient Inclusion Criteria:
SSc Patient Inclusion Criteria:
AAV Patient Inclusion Criteria:
IIM Patients Inclusion Criteria:
Sjögren's Syndrome (SS) Patient Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Shi | Contact | +86 18652756469 | xiao.shi@bioheng.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First People's Hospital of Lianyungang | Recruiting | Lianyungang | Jiangus | 222000 | China |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D056647 | Systemic Vasculitis |
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| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |