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| Name | Class |
|---|---|
| Shanghai Xiniao Biotech Co., Ltd. | INDUSTRY |
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This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.
This is an investigator-initiated trial to evaluate the safety and efficacy ofuniversal allogeneic anti-CD19/BCMA CAR T-cells in Patients With Relapse/Refractory Autoimmune Diseases.
Study intervention consists of a single infusion of universal allogeneic CART-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCAR T-cell group | Experimental | Participants will receive the following interventions and dose escalated per protocol: Biological: UCAR-T cells Drug: Cyclophosphamide Drug: Fludarabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCAR-T cells | Biological | UCAR-T cells will be administered intravenously as per the schedule specified in the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of UCAR T-cell in participants with relapse/ refractory autoimmune diseases | The incidence and severity of adverse events (AEs) | 2 years |
| To evaluate the clinical responses and duration of UCAR-T cells in participants with relapse/ refractory autoimmune diseases | Proportion of participants achieving SRI-4 response, change in the Systemic Lupus Erythematosus Disease Activity Index(SLEDAI) from baseline | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases | AUC0-28d | 2 years |
| To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | China |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Cyclophosphamide | Drug | Cyclophosphamide will be administered intravenously. |
|
| Fludarabine | Drug | Fludarabine will be administered intravenously. |
|
Cmax
| 2 years |
| To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases | Tmax | 2 years |
| To characterize pharmacodynamics of of UCAR-T cells in participants. | Changes in B-cell levels in the peripheral blood from baseline. | 2 years |
| D012871 | Skin Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |