Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Systemic Lupus Erythematosus
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 efficacy of CD19 CAR T cells in the treatment of Systemic lupus erythematosus (SLE).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, aged 3-65 years.
Have a diagnosis of SLE and meet the classification criteria of 2019 European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).
Positive antinuclear antibody (ANA): ANA at a titer of ≥ 1:80 on Hep-2 cells or equivalent positive test (ever) and/or a positive anti-dsDNA serum antibody test (based on ELISA assay, ≥ 30 IU/mL).
CD19+ on B cells and continuous withdrawal of the immunosuppressive drugs for more than 1 week.
Disqualifiers
Intracranial pressure elevation was above 15 mmHg;
Organic encephalopathy syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis, visual impairment, and other brain lesions requiring intervention.
Previously documented left ventricular ejection fraction (LVEF) by echocardiography of <45% in the 12 months;
Abnormal electrocardiogram (ECG): left bundle branch block, bifascicular block or any clinically meaningful ECG abnormality;
Trial design
Design model
Single group
Treatments tested in this trial
CD19 CAR-T cells
DrugFollowing lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: CD19 CARExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase I: Dose-limiting toxicity (DLT)
The incidence and type of dose-limiting toxicity (DLT).
Time frame
28 days post infusion2
Phase I: Adverse events (AEs)
The incidence and severity of adverse events (AE).
Time frame
30 days post infusion3
Phase II: Objective response rate (ORR)
Proportions of subjects achieving SLE Responder Index (SRI)-4 response
Time frame
3 months and 6 months post infusionSecondary outcomes
1
Phase I: Objective response rate (ORR)
Proportions of subjects achieving SLE Responder Index (SRI)-4 response.
Time frame
3 months and 6 months2
Phase I: Long-term Adverse events (AEs)
Total number, incidence and severity of AEs from 30 days to 2 years after CD19 CAR T infusion will be recorded.
Time frame
From 30 days after CD19 CAR T infusion to 2 years3
Phase I: Pharmacokinetics
The proliferation and survival of CD19 CAR T cells will be measured by flow cytometry and quantitative polymerase chain reaction (qPCR).
Time frame
Up to 2 years post infusion4
Phase II: Adverse events (AEs)
The incidence and severity of adverse events.
Time frame
2 years post infusionSponsors and contacts
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Source ClinicalTrials.gov