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Investigator-initiated, single-arm, open-label, single dose clinical study to evaluate the safety and preliminary efficacy of CNCT19 in treatment of patients with refractory systemic lupus erythematosus(SLE) presented with active lupus nephritis or active immune thrombocytopenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CNCT19 cell injetion | Experimental | CNCT19 administration:0.25 to 0.5 x 10^8 CAR-positive viable |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNCT19 cell injection | Drug | Leukapheresis and manufacturing of CNCT19: enrolled subjects will undergo a leukapheresis to target a yield of > 1x 10^9 mononuclear cells
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 1 year |
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Inclusion Criteria:
Group1:Have active, biopsy-proven proliferative lupus nephritis Class III or IV, or Class V using the 2003 ISN/RPS criteria. The biopsy must be performed in the 6 months prior to the screening visit or during the screening period. Have documentation of active renal disease defined as:24h Proteinuria> 1.5 grams/day.
Refractory lupus nephritis is defined as no induced remission to treatment regimens containing at least one immunosuppressant (including glucocorticoids, CTX, tacrolimus, MMF, and cyclosporine) after 3 to 6 months, accompanied by no reduction (or worsening) of proteinuria or persistent antibody positives.
Group 2: Refractory thrombocytopenia: No response to treatment with at least 1 course of MP shock (1g for 3 days) or high dose of glucocorticoids (1mg/kgd equivalent dose of glucocorticoids) combined with 1 or more immunosuppressants. Before enrollment, at least 2 consecutive blood routine tests were performed to check platelets below 50×10^9/L and above 30×10^9/L. Other non-SLE causes of thrombocytopenia, such as infection, bone marrow suppression, and hypersplenism, were excluded.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaofeng Zeng, Dr | Peking Union Medical College Hospital | Principal Investigator |
| Daobin Zhou, Dr | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiaofeng Zeng | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41856114 | Derived | Li M, Zhao J, Lu ZJ, Ning C, Jiang N, Zhang Y, Li Y, Feng Y, Wang Q, Xu D, Leng X, Li J, Zhang S, Wang Z, Peng L, Tian X, Lv L, Zhou D, Zeng X. Anti-CD19 CAR T cell therapy for refractory SLE-ITP. Med. 2026 Apr 10;7(4):101039. doi: 10.1016/j.medj.2026.101039. Epub 2026 Mar 18. |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D008181 | Lupus Nephritis |
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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refractory systemic lupus erythematosus(SLE) presented with active lupus nephritis or active immune thrombocytopenia.
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|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |