Treatment of relapsed autoimmune diseases with UTAA09 injection

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

This study is testing a new injection called UTAA09 to see if it can help people with autoimmune diseases that haven't improved with other treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. (industry)
• Drugs / interventions: CAR-T
• Locations: 1 site (Hefei)
• Trial ID: NCT06361745 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and initial efficacy of UTAA09 injection in patients suffering from relapsed or refractory autoimmune diseases. It is designed as a single-arm, open-label study where participants receive the injection and undergo various assessments, including pharmacokinetics, pharmacodynamics, and immunogenicity evaluations. Blood samples will be collected before and after the infusion to monitor these parameters, and therapeutic efficacy will be assessed at multiple time points over a period of up to 24 months. The study aims to provide insights into the potential benefits of this treatment for patients who have not responded to standard therapies.

Who should consider this trial

Good fit: Ideal candidates include individuals with relapsed or refractory autoimmune diseases who have failed standard treatments.

Not a fit: Patients with stable autoimmune diseases or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with difficult-to-treat autoimmune diseases.

How similar studies have performed: While there have been studies on similar approaches, the specific use of UTAA09 injection in this context is novel and has not been extensively tested.

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.

Where this trial is running

Hefei

• PersonGen.Anke Cellular Therapeutice Co., Ltd — Hefei, China (RECRUITING)

Study contacts

• Principal investigator: songlou yin, master — The Affiliated Hospital of Xuzhou Medical University
• Study coordinator: songlou yin, master

Conditions: Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, IgG4 Related Disease, Primary Sjögren Syndrome