NCT07001956 The Clinical Study on the Treatment of Refractory RA With UTAA91 Injection
| NCT ID | NCT07001956 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Rheumatoid Arthritis (RA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-05-30 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2025-05-30 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 refractory moderate - to - severe active rheumatoid arthritis.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07001956 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rheumatoid Arthritis (RA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07001956 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07001956 currently recruiting?
Yes, NCT07001956 is actively recruiting participants. Contact the research team at qiubaili@hust.edu.cn for enrollment information.
Where is the NCT07001956 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07001956 clinical trial?
NCT07001956 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 24 participants.
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