CAR-T Cells Targeting Autoimmune Diseases
ConditionAutoimmune Diseases
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen Geno-Immune Medical Institute
About this trial
The purpose of this study is to assess the feasibility, safety and efficacy of CAR-T cell therapy in patients with autoimmune disease. Another goal of the study is to learn more about the safety and function of the CAR-T cells and their persistency in autoimmune disease patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age older than 18 years.
expression of B cell surface molecules.
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
Design model
Single group
Treatments tested in this trial
4SCAR T cells
Biological/VaccineInfusion of 4SCAR T cells at 10\^6 cells/kg body weight via IV
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: 4SCAR T Cell Therapy for autoimmune diseasesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of 4SCAR T cells in patients with autoimmune diseases
Safety of 4SCAR T cells in patients with autoimmune diseases using CTCAE 5 standard to evaluate the level of adverse events
Time frame
12 weeksSecondary outcomes
1
B cell and immunoglobulin suppression activity of 4SCAR T cells in patients with autoimmune diseases
scale of CAR copies (for efficacy)
Time frame
1 year2
B cell and immunoglobulin suppression activity of 4SCAR T cells in patients with autoimmune diseases
immunoglobulin levels (for efficacy)
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: