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New treatment option for Rheumatoid Arthritis (RA)
Official title The Clinical Study on the Treatment of Refractory RA With UTAA91 Injection
ClinicalTrials.gov ID: NCT07001956
What this study is testing
What is UTAA91 injection?
UTAA91 injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for rheumatoid arthritis (ra).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged ≥18 years (inclusive of the boundary value), with no restriction on gender.
- Expected survival time of at least 3 months.
- people 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.
You likely can't join if
- A history of malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years prior to screening.
- people 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...
- Pregnant or breastfeeding women, female people planning to become pregnant within 2 years after cell infusion, or male people whose partners plan to...
- people who have received CAR - T therapy or other gene - modified cell therapies before screening.
See the full eligibility criteria
- Aged ≥18 years (inclusive of the boundary value), with no restriction on gender.
- Expected survival time of at least 3 months.
- people 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.
- A history of malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years prior to screening.
- people 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 people planning to become pregnant within 2 years after cell infusion, or male people whose partners plan to become pregnant within 2 years after their cell infusion.
- people who have received CAR - T therapy or other gene - modified cell therapies before screening.
- people who participated in other clinical studies within 1 month before screening.
- Other conditions deemed unsuitable for enrollment by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.