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Not yet recruiting NCT06970951

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

Early Phase I Interventional Systemic Lupus Erythematosus Rheumatoid Arthritis Dry Syndrome Idiopathic Inflammatory Myopathies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: UTAA91 injection.
Who it may be relevant to
Registry conditions: Systemic Lupus Erythematosus, Rheumatoid Arthritis, Dry Syndrome, Idiopathic Inflammatory Myopathies. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-Arm, Open-Label, Single-Center Investigator-Initiated Early-Stage Clinical Study for Relapsed/Refractory (R/R) Autoimmune Diseases

Overview

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.

Interventions

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

Primary outcome measures

  • Adverse events [Time frame: About 1 year]
Secondary outcome measures (3)
  • Cmax [Time frame: About 1 year]
  • Tmax [Time frame: About 1 year]
  • Disease remission rate [Time frame: About 3 months]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years (including the cut - off value), with no restrictions on gender.
  • Expected survival time ≥ 3 months.
  • 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.
  • Liver and kidney functions and cardiopulmonary functions meet the requirements.
  • No severe mental disorders.
  • Able to understand this trial and have signed the informed consent form.

Exclusion criteria

  • Malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years before screening.
  • Subjects with positive virus and/or syphilis tests.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT06970951 · PG-009-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗