A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy

Incidence and severity of adverse events (AE)

Incidence and severity of adverse events (AE) and serious adverse events (SAE) during the study

Time frame: Throughout the first 24 months follow up period completion

MS: No Evidence of Disease Activity-3 (NEDA-3)

Proportion of participants achieving NEDA-3 at 6 months post-infusion and during the study period

Time frame: 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).

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: Throughout the first 24 months follow up period completion

PK：Maximal plasma concentration (Cmax)

Cmax of C-CAR168 in peripheral blood

Time frame: 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

Time frame: Throughout the first 24 months follow up period completion

PK: Duration in peripheral blood (Tlast)

Tlast of C-CAR168 in peripheral blood

Time frame: Throughout the first 24 months follow up period completion

PK: Area under curve (AUC)

AUC of C-CAR168 in peripheral blood

Time frame: Throughout the first 24 months follow up period completion

PD: Depletion of peripheral blood B cells, plasma cells, and CD20dim T cells

Time frame: Throughout the first 24 months follow up period completion

PD: Decline of serum immunoglobulin

Time frame: Throughout the first 24 months follow up period completion