Clinical Study of CD7 CAR-T Cells for Relapsed/refractory Autoimmune Diseases

Launched by PERSONGEN BIOTHERAPEUTICS (SUZHOU) CO., LTD. · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment using CD7 CAR-T cells for patients with systemic sclerosis, a type of autoimmune disease that can cause hardening and tightening of the skin and connective tissues. The main goal is to see how safe this treatment is for patients whose disease has not improved with other treatments. Participants will receive a single infusion of these special CAR-T cells, which are designed to help the immune system fight the disease. Blood tests will be done before and after the infusion to monitor how the body responds to the treatment.

To be eligible for the trial, participants must be between the ages of 18 and 75 and have been diagnosed with relapsing or refractory systemic sclerosis that has not responded to at least two other treatments. They should also have stable heart, liver, and kidney function and no serious mental health disorders. However, people with certain health conditions, like recent cancer or severe heart disease, cannot participate. This trial is not currently recruiting participants, but it represents an important step in exploring new options for patients with challenging autoimmune diseases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - Diagnosed relapsing/refractory systemic sclerosis that has failed treatment with at least two immunosuppressive and/or biologic agents.
• • Bone marrow and coagulation function, liver and kidney function, cardiopulmonary function are satisfied No serious mental disorders
• Exclusion Criteria:
• • - Malignancy other than AID disease within 5 years prior to screening Hepatitis B surface antigen (HBsAg) positive, AIDS, syphilis and other virus positive persons Severe heart disease