JY231(JY231) Injection for the Treatment of Refractory Autoimmune Diseases (ADs)
ConditionAutoimmune Diseases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHe Huang
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 (ADs). It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of Refractory Autoimmune Diseases (ADs).
Eligibility criteria
Qualifiers
Age: 18~75 years old, male or female, signed informed consent (ICF);
Systemic Lupus Erythematosus (SLE), European League Against Rheumatism/ (EULAR)/American College of Rheumatology(ACR) 2019 criteria), and Antinuclear Antibodies(ANA) > 1:80 or ds-DNA positive;
Dry syndrome (SS), 2016 ACR/EULAR criteria and at least Sjögren's Syndrome Antigen A(SSA) positive;
Systemic sclerosis (SSc), 2013 ACR/EULAR criteria and ANA > 1:80 or anti-Scleroderma(SCL)-70 positive;
Disqualifiers
Have received prior CAR-T cell therapy;
Suffering from severe cardiac, hepatic, pulmonary, hematologic, or endocrine system disorders that, in the judgment of the investigator, outweigh the risks of participation in the study;
Active or uncontrollable infection requiring systemic therapy within 1 week prior to screening;
Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) positive and peripheral blood Hepatitis B virus (HBV) DNA titer test is greater than the normal reference range; or Hepatitis C virus (HCV) antibody positive and peripheral blood Hepatitis C virus (HCV) RNA titer test is greater than the normal reference range; or Human Immunodeficiency Virus (HIV) antibody positive; or positive syphilis test; or positive cytomegalovirus (CMV) DNA test;
Trial design
Treatments tested in this trial
- JY231 Injection
Treatment groups
45 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
He Huang
Lead sponsor
Zhejiang University
Sponsor institution
Source ClinicalTrials.gov