Not provided
Not provided
Not provided
Not provided
Not provided
Internal decision.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai Xiniao Biotech Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells(QT-019C) in With Relapse/Refractory Autoimmune Diseases.
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases.
Study intervention consists of a single infusion of universal allogeneic CAR T-cells administered intravenously after a lymphodepleting therapy regimen consisting of cyclophosphamide.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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(QT-019C) Drug: Cyclophosphamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCAR-T cells | Biological | QT-019C will be administered intravenously as per the schedule specified in the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number and severity of dose-limiting toxicity (DLT) events | DLT will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. | Within 28 Days After QT-019C infusion |
| 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 pharmacodynamics of of UCAR-T cells in participants. | Changes in B-cell levels in the peripheral blood from baseline. | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D009220 | Myositis |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |