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This is a phase 1, open-label, non-randomized study enrolling pediatric and young adult research participants with treatment-refractory Systemic Lupus Erythematosus (SLE), to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to express CD19 specific chimeric antigen receptor (CAR)
A child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have their T cells collected. The T cells will then be bioengineered into a CAR T cell that targets circulating and tissue residing B cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCRI-CAR19v3 | Experimental | Single infusion of SCRI-CAR19v3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCRI-CAR19v3 | Biological | Single infusion of SCRI-CAR19v3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | The investigators will assess and described the type, frequency, severity, and duration of adverse events associated with the CAR T cell product. | 28 days post-infusion |
| Rate of SCRI-CAR19v3 Manufacturing Success | We will measure the number of successfully manufactured SCRI-CAR19v3 products. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaun Jackson, MD | Contact | 206-987-3897 | Shaun.Jackson@seattlechildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Shaun Jackson, MD | Seattle Children's Hospital | Study Chair |
| Colleen Annesley, MD | Seattle Children's Hospital | Study Director |
| Corinne Summers, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Recruiting | Seattle | Washington | 98105 | United States |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Seattle Children's Hospital |
| Study Director |