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This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r/r SLE and r/r IIM.
This is a prospective, single-arm, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LUCAR-G79D, a chimeric antigen receptor (CAR) -T cell therapy in subjects with r/r SLE and r/r IIM. Patients who meet the eligibility criteria will receive LUCAR-G79D infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment (LUCAR-G79D infusion) and follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chimeric antigen receptor T cells (LUCAR-G79D) | Experimental | Each subject will be given a single-dose LUCAR-G79D cells infusion at each dose level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LUCAR-G79D T cells | Biological | Prior to infusion of the LUCAR-G79D T cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity, and type of treatment-emergent adverse events (TEAEs) | 2 years after LUCAR-G79D infusion (Day 1) | |
| Incidence of dose-limiting toxicity (DLT) | 2 years after LUCAR-G79D infusion (Day 1) | |
| Maximum concentration (Cmax) in peripheral blood | 2 years after LUCAR-G79D infusion (Day 1) | |
| Time of maximum concentration (Tmax) in peripheral blood | 2 years after LUCAR-G79D infusion (Day 1) | |
| Area under the concentration-time curve (AUC) in peripheral blood | 2 years after LUCAR-G79D infusion (Day 1) | |
| Recommended Dose regimen finding | 2 years after LUCAR-G79D infusion (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 52 weeks for r/r SLE subjects | SLEDAI-2K is a scale ranging from 0 to 105 points, with higher scores indicating stronger disease activity | 52 weeks after LUCAR-G79D infusion (Day 1) |
| Change in manual muscle testing (MMT-8) scores from baseline up to 52 weeks for r/r IIM subjects |
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Inclusion Criteria:
SLE:
IIM:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third The People's Hospital of Bengbu | Recruiting | Bengbu | Anhui | China |
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MMT-8 is a scale ranging from 0 to 80 points, with higher scores indicating greater preserved muscle strength |
| 52 weeks after LUCAR-G79D infusion (Day 1) |
| Changes from baseline in peripheral blood immunoglobulins from baseline up to 52 weeks for all subjects | Including IgG、IgM、IgA、IgE | 52 weeks after LUCAR-G79D infusion (Day 1) |
| Changes from baseline in anti-drug antibody from baseline up to 52 weeks for all subjects | 52 weeks after LUCAR-G79D infusion (Day 1) |
| Nanfang Hospital | Not yet recruiting | Guangzhou | Guangdong | China |
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| Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | China |
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| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | China |
|
| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | China |
|
| 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 |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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