Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-18

Study Completion Date

2027-04-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Systemic Lupus Erythematosus Rheumatoid Arthritis Dry Syndrome Idiopathic Inflammatory Myopathies Systemic Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

UTAA91 injection

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UTAA91 injection

Infusion of UTAA91 injection in subjects screened after signing informed consent.

Group Type EXPERIMENTAL

UTAA91 injection

Intervention Type BIOLOGICAL

Infusion of UTAA91 injection in subjects screened after signing informed consent.

Interventions

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UTAA91 injection

Infusion of UTAA91 injection in subjects screened after signing informed consent.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No