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

Subjects who meet the inclusion/exclusion criteria will be entered into 3 groups in sequential order for a single dose. The dose-escalation study utilizes a "3+3" design, i.e., 3-6 subjects in each group will complete a single dose.

After the last subject in each dose group completes a dose-limiting toxicity (DLT) assessment window of 28 days after the single dose, enrollment in the next dose group can begin.

When 1 DLT occurs in 3 subjects in a dose group, 3 additional subjects are required in the same dose group (up to 6 subjects in that dose group have completed DLT assessment): if no ...

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

Trial Officials