Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases

Launched by PERSONGEN BIOTHERAPEUTICS (SUZHOU) CO., LTD. · Apr 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called UTAA09 injection for patients with relapsed or refractory autoimmune diseases. Autoimmune diseases occur when the body’s immune system mistakenly attacks its own tissues. The trial aims to assess how safe UTAA09 is, how it behaves in the body (this is called pharmacokinetics), how it affects the body’s immune response (pharmacodynamics), and its initial effectiveness in treating these diseases. Conditions included in the study are systemic lupus erythematosus, idiopathic inflammatory myopathies, systemic sclerosis, IgG4-related disease, and primary Sjögren syndrome.

To participate, individuals must be between 65 and 74 years old and have been diagnosed with one of the specified autoimmune diseases that have not responded to standard treatments. They should be able to understand the trial and provide informed consent. Participants will receive the UTAA09 injection and will be monitored for safety and effectiveness during the study. It's important to note that certain medical conditions, such as serious heart disease or active infections, may prevent someone from joining the trial. The study is currently recruiting, and participants can expect close supervision and support throughout the process.

Gender

ALL

Eligibility criteria

• • inclusion criteria (2) Expected survival time ≥3 months; (3) Subjects with recurrent/refractory autoimmune diseases who have failed standard treatment or lack effective treatment, Including but not limited to systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, IGG4-associated diseases, primary Sjogren's syndrome, rheumatoid arthritis, connective tissue disease-associated interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc.
• • (3) Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction.
• (4) Liver and kidney function, cardiopulmonary function meet the following requirements:
• • Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands;
• • Blood oxygen saturation \>91% in non-oxygen state;
• • Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; ALT and AST abnormalities due to disease, such as liver infiltration or bile duct obstruction, were determined to be less than 5×ULN. If Gilbert syndrome is diagnosed, the total bilirubin index can be relaxed to ≤3.0×ULN and the direct bilirubin ≤1.5×ULN.
• • (5) no serious mental disorders; (6) Can understand this test and have signed the informed consent.
• Exclusion criteria:
• • 1. Malignant tumors other than R/R AID disease in the 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;
• • 2. Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) Antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) Antibody positive; Syphilis positive;
• • 3. Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmia;
• • 4. Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment;
• • 5. Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days prior to administration;
• • 6. Pregnant or lactating women, and female subjects who plan pregnancy within 2 years after cell transfusion or male subjects whose partners plan pregnancy within 2 years after cell transfusion;
• • 7. Patients who received CAR-T therapy or other gene-modified cell therapy before screening;
• • 8. Participated in other clinical studies 1 month before screening;
• • 9. Evidence of central nervous system invasion during subject screening;
• • 10. Mental patients with depression or suicidal thoughts;
• • 11. Those who received live vaccine within 28 days prior to screening;
• • 12. Situations considered unsuitable for inclusion by other researchers.