This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.
This is an investigator-initiated trial to evaluate the safety and efficacy ofuniversal allogeneic anti-CD19/BCMA CAR T-cells in Patients With Relapse/Refractory Autoimmune Diseases. Study intervention consists of a single infusion of universal allogeneic CART-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
A single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells
Changzhou No.2 People's Hospital
Changzhou, China
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.
Time frame: Within 28 Days After UCAR T-cell Infusion
The total number, incidence, and severity of AEs
Time frame: Up to 90 days After UCAR T-cell Infusion
AIHA：Rates of CR, CRi, PR, ORR
CR: complete response CRi: Complete Remission with incomplete and compensated hemolysis PR: Partial response ORR: Overall response rate
Time frame: Up to 24 Months After UCAR T-cell Infusion
SLE：SLE Response Index 4 (SRI-4)
The SRI-4 (SLE Responder Index-4) response was defined as a reduction of at least 4 points in SLEDAI score compared with the baseline level, no new British Isles Lupus Assessment Group (BILAG) A organ domain score or no more than one new BILAG B organ domain score, and no worsening in the Physician's Global Assessment (PGA) (\<0.3 points worsening from the baseline level).
Time frame: Up to 24 Months After UCAR T-cell Infusion
SLE: Change in the Systemic Lupus Erythematosus Disease Activity Index(SLEDAI) from baseline
SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index, with a score of 0-6 representing mild disease activity, 7-12 representing moderate disease activity, and 12-16 representing severe disease activity
Time frame: Up to 24 Months After UCAR T-cell Infusion
SSc：Change in the modified Rodnan Skin Score (mRSS) from baseline
The modified Rodnan Skin Score (mRSS) describes the thickness of skin in 17 anatomic areas rated from 0 to 3, where 3 indicates the most severe thickening.
Time frame: Up to 24 Months After UCAR T-cell Infusion
IIM：The ACR-EULAR Myositis Response Criteria [Total Improvement Score (TIS)]
Total Improvement Score (TIS) contains Physician Global Activity(PGA)，Patient/Parent Global Activity(PtGA)，Manual Muscle Testing(MMT) and Health Assessment Questionnaire(HAQ). PGA:This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. visual analogue scale and a 5 point Likert scale. PtGA:This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale. MMT:This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies. HAQ:Define the health assessement questionnaire.
Time frame: Up to 24 Months After UCAR T-cell Infusion
AAV: Change in disease activity as measured by Birmingham Vasculitis Activity Score (BVAS)
The Birmingham Vasculitis Activity (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). A negative percentage change indicated improvement in health.
Time frame: Up to 24 Months After UCAR T-cell Infusion
IgG4-RD:IgG4-Related Disease Responder Index (IgG4-RD RI)
The IgG4-RD RI detects change in disease activity and identifies improvements/worsening in the same or different organ systems. It encompasses more than 25 organs/sites and records the following for each organ/site: (i) activity trend (through a 0-3 \[normal/resolved - worsening\] organ/site score); (ii) presence of symptoms due to active disease; (iii) need for urgent care; (iv) presence of damage; and (v) presence of symptoms due to damage. The final activity score at each visit is obtained by summing all organ/site scores (i) and by doubling items needing urgent care (iii). Higher scores represent greater (i.e. worse) disease activity.
Time frame: Up to 24 Months After UCAR T-cell Infusion
MG:Changes of Myasthenia Gravis Activities of Daily Living (MG-ADL) Score
MG-ADL scale assesses the impact of gMG on daily functions by measuring 8 signs or symptoms that are commonly affected in MG. Each item is measured on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents the loss of ability to perform that function. Total scores range from 0 to 24 points, with a higher score showing more severe MG.
Time frame: Up to 24 Months After UCAR T-cell Infusion
MG:Quantitative Myasthenia Gravis Score (QMG)
The QMG score is a 13-item scale used to quantify disease severity in myasthenia gravis. The scale measures ocular, bulbar, respiratory, and limb function, grading each finding, and ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits).
Time frame: Up to 24 Months After UCAR T-cell Infusion
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