Clinical Study on the Treatment of Systemic Sclerosis With UTAA91 Injection.

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPersonGen BioTherapeutics (Suzhou) Co., Ltd.

About this trial

This clinical trial is designed as a single-arm, open-label, single-center investigator-initiated early-phase study, with the primary objective of evaluating the safety of UTAA91 injection in subjects with refractory moderate-to-severe active systemic sclerosis.

Eligibility criteria

Qualifiers

Aged ≥18 years (inclusive of the boundary value), with no restriction on gender.

Expected survival time of ≥3 months.

Refractory moderate - to - severe active systemic sclerosis that has failed standard treatment or lacks effective therapeutic options.

Meets the requirements for liver and kidney function, as well as cardiopulmonary function.

Disqualifiers

A history of malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years prior to screening.

Positive results in virology/syphilis tests.

Severe cardiac diseases or unstable systemic diseases.

Presence of active or uncontrollable infections requiring systemic treatment, or evidence of central nervous system invasion.

Trial design

Treatments tested in this trial

  • UTAA91 injection

Treatment groups

24 Participants
are divided into 1 treatment group