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| Name | Class |
|---|---|
| Shanghai AbelZeta Ltd. | INDUSTRY |
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This is an investigator-initiated, single-center, 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 Autologous C-CAR168 administered by intravenous (IV) infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD20/BCMA-directed CAR-T cells Autologous 2nd generation | Biological | CD20/BCMA-directed CAR-T cells, single infusion intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of Adverse Events [Safety and Tolerability] | Incidence and severity of adverse events (AE) and serious adverse events (SAE) within three months following infusion | Throughout the first 3 months follow up period completion |
| The subsequent recommended dose of C-CAR168 in patients with autoimmune diseases refractory to standard therapy | Based on the assessment of overall safety profile | Throughout the first 24 months follow up period completion |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AE) | Incidence and severity of adverse events (AE) and serious adverse events (SAE) during the study | Throughout the first 24 months follow up period completion |
| MS: No Evidence of Disease Activity-3 (NEDA-3) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum cytokines changes | Detection of serum cytokines changes over time by flow cytometry | Throughout the first 24 months follow up period completion |
| Soluble BCMA changes in peripheral blood | Detection of soluble BCMA changes in peripheral blood by Enzyme Linked ImmunoSorbent Assay (ELISA) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Liu, MD | Contact | 17853297267 | liumin1968@yeah.net | |
| Bin Liu, MD | Contact | 18661806287 | 053282919030 | Binliu72314@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Qingdao | Qindao, Shandong | 266003 | China |
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|
Proportion of participants achieving NEDA-3 at 6 months post-infusion and during the study period
| Throughout the first 24 months follow up period completion |
| MS and NMOSD: Expanded Disability Status Scale (EDSS) | Change from baseline in EDSS at 6 months and 24 months post-infusion. EDSS and its associated functional system(FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death). | Throughout the first 24 months follow up period completion |
| MS and NMOSD: MRI | Number of T1 gadolinium-enhancing lesions and new or enlarging T2 lesions, as well as their change from baseline,at 6 months and 24 months post-infusion. Change from baseline in total T2 lesion volume, gray matter volume (GMV),white matter volume (WMV), and brain volume (BV), as well as annualized-brain volume loss (a-BVL), at 6 months and 24 months post-infusion | Throughout the first 24 months follow up period completion |
| MS and NMOSD: Annualized Relapse Rate (ARR) | ARR at 6 months and 24 months post-infusion | Throughout the first 24 months follow up period completion |
| MG: Minimal Symptom Expression (MSE) and Minimal Clinically Important Difference (MCID) | Proportion of participants achieving MSE or MCID at 6 months and 24 months post-infusion | Throughout the first 24 months follow up period completion |
| MG: Quantitative Myasthenia Gravis Score (QMGS) | Change from baseline in QMGS at 6 months and 24 months post-infusion. The Quantitative Myasthenia Gravis Score (QMGS) has a score range from 0 to 39, and higher scores indicate a worse clinical outcome. | Throughout the first 24 months follow up period completion |
| MG: Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale | Change from baseline in MG-ADL at 6 months and 24 months post-infusion. The Myasthenia Gravis Activities of Daily Living (MG-ADL) Scale has a score range from 0 to 24, and higher scores indicate a worse clinical outcome. | Throughout the first 24 months follow up period completion |
| SLE: Definition Of Remission In SLE (DORIS), Lupus Low Disease Activity State (LLDAS), Systemic Lupus Erythematosus Responder Index-4 (SRI-4) | Proportion of participants achieving DORIS or LLDAS or SRI-4 at 6 months post-infusion and during the study period | Throughout the first 24 months follow up period completion |
| SLE: Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K), | Change from baseline in SLEDAI-2K at 6 months and 24 months post-infusion. SLEDAI-2K is a validated global disease-activity index that quantifies SLE activity by rating the presence of 24 weighted clinical and laboratory descriptors across 9 organ systems (central nervous/visual, vascular, renal, musculoskeletal, cutaneous, mucosal/serosal, constitutional, and immunologic/hematologic) occurring within the prior 10 days. Each descriptor is credited only if attributable to active lupus (not infection, drug effect, metabolic cause, or unrelated comorbidity); descriptors are summed for a total score range 0-105, with higher scores indicating greater disease activity. | Throughout the first 24 months follow up period completion |
| IMNM: Definition Of Improvement (DOI) | Proportion of participants achieving DOI at 6 months post-infusion and during the study period | Throughout the first 24 months follow up period completion |
| IMNM: Manual Muscle Test (MMT) | Change from baseline in MMT at 6 months and 24 months post-infusion. MMT scale is a foundational, internationally recognized clinical tool for quantifying voluntary skeletal muscle strength in patients with neurologic and systemic diseases. | Throughout the first 24 months follow up period completion |
| SSc: Revised Composite Response Index in Systemic Sclerosis (r-CRISS) | Proportion of participants achieving r-CRISS at 6 months post-infusion and during the | Throughout the first 24 months follow up period completion |
| SSc: modified Rodnan Skin Score (mRSS), FVC% | Change from baseline in mRSS and FVC% at 6 months and 24 months post-infusion. mRSS is the international standard semi quantitative measure of skin thickening in SSc. Scores are summed for a total range of 0-51, with higher scores indicating greater skin involvement. | Throughout the first 24 months follow up period completion |
| PK：Maximal plasma concentration (Cmax) | Cmax of C-CAR168 in peripheral blood | Throughout the first 24 months follow up period completion |
| PK: Time to reach the maximal plasma concentration (Tmax) | Tmax of C-CAR168 in peripheral blood | Throughout the first 24 months follow up period completion |
| PK: Duration in peripheral blood (Tlast) | Tlast of C-CAR168 in peripheral blood | Throughout the first 24 months follow up period completion |
| PK: Area under curve (AUC) | AUC of C-CAR168 in peripheral blood | Throughout the first 24 months follow up period completion |
| PD: Depletion of peripheral blood B cells, plasma cells, and CD20dim T cells | Throughout the first 24 months follow up period completion |
| PD: Decline of serum immunoglobulin | Throughout the first 24 months follow up period completion |
| Throughout the first 24 months follow up period completion |
| Changes in CSF CAR DNA copy number and CAR-T cells | Detection of changes in CSF CAR DNA copy number and CAR-T cells by quantitative polymerase chain reaction (qPCR) and flow cytometry | Throughout the first 24 months follow up period completion |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009157 | Myasthenia Gravis |
| D009471 | Neuromyelitis Optica |
| D008180 | Lupus Erythematosus, Systemic |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System 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 |
| D009188 | Myelitis, Transverse |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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