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This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV, IIM and pSS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | RD06-04ï¼›RD06-05 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19 or CD19-BCMA CAR-T | 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 CAR-T 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 CAR-T 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 | |
|---|---|---|---|---|
| Peng Yu | Contact | 18451117657 | peng.yu@bioheng.com | |
| Ming Gao | Contact | 17714188689 | ming.gao@bioheng.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third the People's Hospital of Bengbu | Recruiting | Bengbu | Anhui | 233000 | China |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D012595 | Scleroderma, Systemic |
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| D009220 | Myositis |
| D012859 | Sjogren's Syndrome |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D012871 | Skin Diseases |
| D056647 | Systemic Vasculitis |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017445 | Skin Diseases, Vascular |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D018941 | Antigens, CD19 |
| ID | Term |
|---|---|
| D015703 | Antigens, CD |
| D000943 | Antigens, Differentiation |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D000944 | Antigens, Differentiation, B-Lymphocyte |
| D015778 | Minor Histocompatibility Antigens |
| D006649 | Histocompatibility Antigens |
| D007519 | Isoantigens |
| D015415 | Biomarkers |
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