CAR-T Therapy for Refractory Autoimmune Diseases
ConditionAutoimmune Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLiangZou
About this trial
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with refractory autoimmune diseases. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of CD19 CAR-T in the treatment of refractory autoimmune diseases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old, regardless of gender, signed with informed consent (ICF).
Diagnosed as one of the following diseases: Systemic lupus erythematosus (SLE)；Sjogren's syndrome (SS) ; Systemic Scleroderma (SSc); Dermatomyositis (DM); Anti neutrophil cytoplasmic antibody associated vasculitis (ANCA-AAV).
For SLE patients, SLEDAI ≥ 8 points;
For SS patients, Sjogren's syndrome disease activity index(ESSDAI )≥ 14 points;
Disqualifiers
Previously received Chimeric Antigen Receptor T cell(CAR-T) therapy;
Suffering from severe diseases of the heart, liver, lungs, blood system, and endocrine system, the researcher has determined that the risk of participating in the trial is higher than the benefit;
Active or uncontrollable infections that require systemic treatment within the first week of screening;
Previously received hematopoietic stem cell transplantation or solid organ transplantation (excluding corneal and hair transplantation), or screened for acute graft-versus-host disease (GVHD) with grade 2 or above in the first two weeks;
Trial design
Design model
Single group
Treatments tested in this trial
JY231 (JY231 injection)
DrugJY231 injection is administered intravenously and produces autologous CAR-T cells in the patient's body some time after infusion.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: CD19 CAR-T for the treatment of refractory autoimmune diseasesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of adverse events(AE) after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Time frame
Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 242
Maximal Tolerated Dose(MTD)
MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.
Time frame
Up to 28 days after infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
LiangZou
Lead sponsor
Shenzhen Genocury Biotech Co., Ltd.
Sponsor institution
Source ClinicalTrials.gov