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| Name | Class |
|---|---|
| Rui Therapeutics Co., Ltd | INDUSTRY |
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A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with relapsed/refractory B-cell related autoimmune diseases.15 patients are planned to be enrolled in the dose-escalation trial (6×10^9 cells, 9×10^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate the effectiveness of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with relapsed/refractory B-cell related autoimmune diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-CD19 CAR NK cells | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-CD19 CAR NK cells | Drug | Patients will receive Fludarabine (30mg/m2 per day) and Cyclophosphamide (300mg/m2 per day) on day -5, -4, and -3, followed by Anti-CD19 CAR NK cells infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicity (DLTs) | To characterize the safety of anti-CD19 CAR NK Cells for moderate to severe autoimmune diseases. | within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion |
| Treatment Emergent Adverse Events(TEAEs) | To characterize the safety of anti-CD19 CAR NK Cells for moderate to severe autoimmune diseases | within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate of subjects | To characterize the efficacy of anti-CD19 CAR NK Cells for moderate to severe autoimmune diseases. Disease control is assessed according to SLEDAl 2K. Disease control rate is defined as proportion of patients with SRI-4 response: including SLEDAI 2K ≥ 4-Point improvement | 4, 12, 24, and 52 weeks after infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Jiangsu University | Recruiting | Zhenjiang | Jiangsu | 212001 | China |
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| Remission rate of subjects | To characterize the efficacy of anti-CD19 CAR NK Cells for moderate to severe autoimmune diseases. Remission is assessed according to SLEDAl 2K. Remission rate is defined as proportion of patients with SLEDAl 2K score= 0 | 4, 12, 24, and 52 weeks after infusion |
| Jiangsu University Affiliated Hospital | Recruiting | Zhenjiang | Jiangsu | 212001 | China |
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