Safety and Efficacy of CD19 CAR-T Therapy for Recurrent/Refractory Autoimmune Diseases
ConditionAutoimmune Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Boren Hospital
About this trial
This study is a single center, open label exploratory clinical trial aimed at evaluating the safety and efficacy of universal CD19 CAR-T therapy in subjects with autoimmune diseases.
The study will adopt the traditional dose escalation model "3+3" design, setting up three dose groups with a starting dose of 0.5 × 106 CAR+T cells/kg for incremental DLT observation. Safety and efficacy follow-up will be conducted for 24 months after cell infusion to observe the safety of the universal CD19 CAR-T and conduct preliminary efficacy evaluation.
Eligibility criteria
Qualifiers
Participants must meet all of the following inclusion criteria in order to be included in this study;
Age range of 18 to 65 years old (including 18 and 65 years old), gender is not limited;
According to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) SLE classification criteria, the diagnosis is SLE;
Positive for anti nuclear antibody (ANA) (titer ≥ 1:80), and/or positive for anti dsDNA antibody, and/or positive for anti Sm antibody during screening;
Disqualifiers
Patients with previous or concurrent active malignant tumors, including tumor associated polymyositis/dermatomyositis. Cervical carcinoma in situ that has been cured or has not recurred for at least 2 years, non-invasive basal cell or squamous cell skin cancer, locally treated prostate cancer, and ductal carcinoma in situ after radical surgery are excluded;
Within the past 3 months, severe pulmonary diseases such as moderate to severe pulmonary arterial hypertension (average pulmonary arterial pressure detected by echocardiography>60 mmHg) require oxygen mask therapy or non-invasive or invasive ventilator assisted breathing during screening; During screening, IgA, IgG, and IgM levels were below the lower limit of normal (LLN);
Individuals who have used B-cell depletion therapy within the previous month and have not failed treatment as assessed by clinical physicians, including those targeting CD20, CD22, CD52, CD38, BCMA monoclonal antibodies, or bispecific antibodies;
Screening for excessive use of human intravenous immunoglobulin within the previous month;
Trial design
Treatments tested in this trial
- CD19 CART
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov