About this trial
The purpose of this study is to assess the feasibility, safety and efficacy of mesenchymal stem cells (MSCs) in combination with CAR-T cells in treating autoimmune disease. Another goal of the study is to learn more about the safety and function of the MSCs combined with CAR-T cells and their long term effects in autoimmune disease patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
older than 18 years of age.
established autoimmune conditions.
the KPS score over 80 points, and survival time is more than 3 months.
greater than Hgb 80 g/L.
Disqualifiers
accompanied with other active diseases and difficult to assess treatment response.
bacterial, fungal, or viral infection, unable to control.
living with HIV.
active HBV or HCV infection.
Trial design
Single group
Treatments tested in this trial
fetal MSCs combined with 4SCAR T cells
Biological/VaccineInfusion of 4SCAR T cells at 10\^6 cells/kg body weight and MSCs at 3x10\^6 cells via IV
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Safety of 4SCAR T cells in patients with autoimmune diseases using CTCAE 5 standard to evaluate the level of adverse events
Safety of 4SCAR T cells in patients with autoimmune diseases using CTCAE 5 standard to evaluate the level of adverse events with measuring cytokine response
Secondary outcomes
Number of participants with reduced symptoms or stabilized conditions after treatment assessed by short term clinical effects
Number of participants with reduced symptoms or stabilized conditions after treatment assessed by short term clinical effects using study assessment table.
The activity of 4SCAR T cells in patients with autoimmune diseases
B cell and immunoglobulin suppression activity of 4SCAR T cells in patients with autoimmune diseases
The activity of 4SCAR T cells in patients with autoimmune diseases
CAR copies in patients with autoimmune diseases
The activity of 4SCAR T cells in patients with autoimmune diseases
The immunoglobulin levels in patients with autoimmune diseases
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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