Clinical Study on the Treatment of Refractory Rheumatoid Arthritis With UTAA91 Injection
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: Rheumatoid Arthritis (RA). 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 →
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Official title
Clinical Study on the Treatment of Refractory Moderate - to - Severe Active Rheumatoid Arthritis With UTAA91 Injection
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 refractory moderate - to - severe active rheumatoid arthritis.
Interventions
- Biological UTAA91 injection
After signing 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 the evaluation of pharmacokinetics, pharmacodynamics, immunogenicity, and safety.
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
- Aged ≥18 years (inclusive of the boundary value), with no restriction on gender.
- Expected survival time of at least 3 months.
- Subjects with refractory moderate - to - severe active rheumatoid arthritis who have failed standard treatment or lack effective therapeutic options.
- Meet the requirements for liver and kidney function, as well as cardiopulmonary function.
- Free from severe psychiatric disorders.
- Able to understand the trial and have signed the informed consent form.
Exclusion criteria
- A history of malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years prior to screening.
- Subjects with positive results in virus/syphilis tests.
- Severe cardiac diseases or unstable systemic diseases.
- Active or uncontrollable infections requiring systemic treatment within 7 days before administration; evidence of central nervous system invasion at screening.
- Pregnant or breastfeeding women, female subjects planning 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.
- Subjects who have received CAR - T therapy or other gene - modified cell therapies before screening.
- Subjects who participated in other clinical studies within 1 month before screening.
- Other conditions deemed unsuitable for enrollment by the investigator.
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
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT06982547 · PG-011-9