Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases
ConditionAutoimmune Diseases
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age3-65
SponsorBeijing GoBroad Hospital
About this trial
The goal of this study is to evaluate the safety and effi cacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases.
Eligibility criteria
Qualifiers
Male or female patients, aged 3-65 years (including 3 and 65 years);
Systemic lupus erythematosus that meets the 2019 American Society of Rheumatology (ACR) / European Association of Rheumatology Consortium (EULAR) classification criteria (see Annex 2);
Nuclear antibody (ANA) test is clearly positive, namely ANA titer 1:80 (based on the equivalent results of Hep-2 immunofluorescence or enzyme immunoassay) and / or the test at the screening visit (based on ELISA test, 30 IU / mL).
Patients take at least 7.5 mg of prednisolone daily to maintain low disease activity or a SLEDAI 2K score (see attachment 3) of 8 or higher.
Disqualifiers
None
Trial design
Treatments tested in this trial
- CD19 CAR-T cells
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov