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
This trial does not accept healthy volunteersQualifiers
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
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: Experimental : 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 Autoimmune Diseases response
Time frame
3 months and 6 months post infusion]Secondary outcomes
1
Phase I: Objective response rate (ORR)
Proportions of subjects achieving Autoimmune Diseases response.
Time frame
3 months and 6 months2
Phase I: Long-term serious adverse events (SAEs)
Total number, incidence and severity of SAEs 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(PK)
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 I: Pharmacodynamic(PD)
The lymphocyte Subsets Detection and cytokine Detection will be measured by flow cytometry.
Time frame
Up to 2 years post infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov