Clinical Study on the Treatment of Refractory Rheumatoid Arthritis With UTAA91 Injection

PersonGen BioTherapeutics

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Rheumatoid Arthritis (RA)

Treatments

Biological: UTAA91 injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT06982547

PG-011-9

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.