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| Name | Class |
|---|---|
| AbelZeta Inc. | INDUSTRY |
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This is an investigator-initiated, multicenter, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-CAR168 | Experimental | Autologous C-CAR168 administered by intravenous (IV) infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD20/BCMA-directed CAR-T cells | Biological | Autologous 2nd generation CD20/BCMA-directed CAR-T cells, single infusion intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events [Safety and Tolerability] | Incidence of any adverse events (AEs), including dose limiting toxicities (DLTs) | Throughout the first 24 months follow up period completion (3 years)，DLTs will be observed/collected throughout the 28 days post C-CAR168 infusion |
| The subsequent recommended dose of C-CAR168 in patients with autoimmune diseases refractory to standard therapy | Based on the assessment of dose-limiting toxicities (DLTs) rates and overall safety profile | Throughout the first 24 months follow up period completion (3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who achieved remission at 6 months (6M) | Throughout the first 6 months follow up period completion (1.5 years) | |
| The proportion of subjects who achieved remission during the main study period | Throughout the first 24 months follow up period completion (3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum cytokines (including Interleukin (IL)-2, IL-4, IL-6, IL-10, Tumor Necrosis Factor (TNF)-α, Interferon (IFN)-γ) changes | Detection of serum cytokines (including IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ) changes over time by flow cytometry | Throughout the first 24 months follow up period completion (3 years) |
| Soluble BCMA changes in peripheral blood |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nan Shen, MD & PhD | Contact | +86-21-63260477 | nanshensibs@gmail.com | |
| Huihua Ding, MD | Contact | +86-21-53882280 | dinghuihua@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Nan Shen, MD & PhD | Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University | Recruiting | Shanghai | Shanghai Municipality | 200001 | China |
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| The proportion of subjects who experienced relapse during the main study period | Throughout the first 24 months follow up period completion (3 years) |
| Time to response (TTR) | The time from the date of C-CAR168 infusion to the first documented remission | Throughout the first 24 months follow up period completion (3 years) |
| Progression-free survival (PFS) | The time from the date of C-CAR168 infusion to the date of first documented disease progression or death, whichever comes first | Throughout the first 24 months follow up period completion (3 years) |
| The proportion of subjects who achieved glucocorticoids/immunosuppressant free and subjects who achieved low-dose glucocorticoids application during the main study period | Throughout the first 24 months follow up period completion (3 years) |
| Maximal plasma concentration (Cmax) | Maximal plasma concentration of C-CAR168 in peripheral blood | Throughout the first 24 months follow up period completion (3 years) |
| Time to reach the maximal plasma concentration (Tmax) | Time to reach the maximal plasma concentration of C-CAR168 in peripheral blood | Throughout the first 24 months follow up period completion (3 years) |
| Duration in peripheral blood (Tlast) | The duration of C-CAR168 in peripheral blood | Throughout the first 24 months follow up period completion (3 years) |
| Area under curve (AUC) | Area under the curve of C-CAR168 in peripheral blood | Throughout the first 24 months follow up period completion (3 years) |
| The clearance of peripheral blood B cell | Throughout the first 24 months follow up period completion (3 years) |
| The decline of serum immunoglobulin | Throughout the first 24 months follow up period completion (3 years) |
| The elevation of peripheral blood complement | Throughout the first 24 months follow up period completion (3 years) |
| The decline of autoantibodies or other disease specific biomarkers | Throughout the first 24 months follow up period completion (3 years) |
Detection of soluble BCMA changes in peripheral blood by Enzyme Linked ImmunoSorbent Assay (ELISA) |
| Throughout the first 24 months follow up period completion (3 years) |
| RNA changes in peripheral blood | Detection of RNA changes in peripheral blood by RNA sequencing | Throughout the first 24 months follow up period completion (3 years) |
| Protective antibodies changes in peripheral blood | Detection of protective antibodies changes in peripheral blood by ELISA | Throughout the first 24 months follow up period completion (3 years) |
| B cells changes in bone marrow, skin, muscle or kidney | Detection of B cells concentration changes in bone marrow, skin, muscle or kidney by flow cytometry | Throughout the first 24 months follow up period completion (3 years) |
| Plasma cells or long-lived plasma cells changes in bone marrow, skin, muscle or kidney | Detection of plasma cells or long-lived plasma cells concentration changes in bone marrow, skin, muscle or kidney by flow cytometry | Throughout the first 24 months follow up period completion (3 years) |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D009471 | Neuromyelitis Optica |
| D009103 | Multiple Sclerosis |
| D009157 | Myasthenia Gravis |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D012871 | Skin Diseases |
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