Clinical trial NCT06970951: Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
Official title: A Single-Arm, Open-Label, Single-Center Investigator-Initiated Early-Stage Clinical Study for Relapsed/Refractory (R/R) Autoimmune Diseases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Systemic Lupus Erythematosus
Rheumatoid Arthritis
Dry Syndrome
Idiopathic Inflammatory Myopathies
Systemic Sclerosis
Lead sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: UTAA91 injection
Primary purpose: TREATMENT

Brief summary: This clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study. The primary objective is to evaluate the safety of UTAA91 injection in treating subjects with relapsed/refractory autoimmune inflammatory diseases (AID).

Detailed description: Following the signing of the informed consent form, eligible subjects will receive an infusion of UTAA91 injection. Blood samples will be collected from the subjects before and after the infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety assessments.

Aside from the baseline period, efficacy evaluations will be conducted periodically during the treatment phase after cell reinfusion until the occurrence of one of the following events, with the earliest event taking precedence: disease progression, initiation of new anti - disease treatment, death, intolerable toxicity, the investigator's decision, or the subject's voluntary withdrawal.

Eligibility criteria: Inclusion Criteria

1. Age ≥ 18 years (including the cut - off value), with no restrictions on gender.
2. Expected survival time ≥ 3 months.
3. Subjects with relapsed/refractory autoimmune diseases who have failed standard treatment or lack effective treatment options, including but not limited to rheumatoid arthritis, systemic sclerosis, systemic lupus erythematosus, idiopathic inflammatory myopathies, Sjögren's syndrome, connective tissue disease - related interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc.
4. Liver and kidney functions and cardiopulmonary functions meet the requirements.
5. No severe mental disorders.
6. Able to understand this trial and have signed the informed consent form.

Exclusion Criteria

1. Malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years before screening.
2. Subjects with positive virus and/or syphilis tests.
3. Presence of severe heart disease or unstable systemic diseases.

5. Presence of active or uncontrollable infections requiring systemic treatment.

6. Pregnant or breastfeeding women, as well as female subjects who plan to become pregnant within 2 years after cell infusion or male subjects whose partners plan to become pregnant within 2 years after their cell infusion.

7. Subjects who have received CAR - T therapy or other gene - modified cell therapies before screening.

Primary outcomes:
measure: Adverse events
timeFrame: About 1 year
Secondary outcomes:
measure: Cmax
timeFrame: About 1 year
measure: Tmax
timeFrame: About 1 year
measure: Disease remission rate
timeFrame: About 3 months
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Jian Wu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: