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

Launched by PERSONGEN BIOTHERAPEUTICS (SUZHOU) CO., LTD. · May 12, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called UTAA09 injection for patients with certain autoimmune diseases that have not responded well to other treatments. Autoimmune diseases like systemic lupus erythematosus, rheumatoid arthritis, and Sjogren's syndrome occur when the body's immune system mistakenly attacks its own tissues. The main goals of this study are to check how safe the injection is, how it moves through the body, and if it can help improve the conditions of patients with these ongoing health challenges.

To participate in this trial, patients should be between 65 and 74 years old and have an autoimmune disease that hasn't improved with standard treatment. They must also have a few health requirements met, such as stable kidney and liver function, and no serious heart problems. Participants will receive the UTAA09 injection and will be monitored for its effects, side effects, and overall safety. It’s important to note that this trial is not yet recruiting participants, so there will be more information available in the future for those who are interested.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (2) Expected survival time ≥3 months; (3) Subjects with recurrent/refractory autoimmune disease who have failed standard treatment or lack effective treatment, including but not limited to systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, Sjogren's syndrome, rheumatoid arthritis, connective tissue disease-associated interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc.
• (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.