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

Not Applicable

Not yet recruiting

• Conditions: Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria
• Interventions: Biological: T cell injection targeting CD7 chimeric antigen receptor

• Registration Number: NCT06871644
• Lead Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Brief Summary

The primary objective was to evaluate the safety of CD7 CAR-T cells for the treatment of subjects with relapsed/refractory AID. CD7 CAR-T cells were infused in a single infusion in subjects who were screened after signing an informed consent form and undergoing single nucleus cell collection and pretreatment, and blood was collected before and after the infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety evaluations.

Detailed Description

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 DLT occurs in the 3 additional subjects, continue the dose escalation; if 1 of the 3 additional subjects develops a DLT, stop the dose escalation; if \>1 of the 3 additional subjects DLT occurs, the dose escalation is stopped and a one-dose reduction is required to continue enrolling 3 more subjects for DLT assessment.

Study Timeline

• Study First Submitted: 2025-02-27
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-12
• Last Update Posted: 2025-03-12
• Study Start: 2025-03-18
• Primary Completion: 2026-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
T cell injection targeting CD7 chimeric antigen receptor	T cell injection targeting CD7 chimeric antigen receptor	CD7 CAR-T cell therapy Subjects meeting the inclusion/exclusion criteria will be entered into the 0.25×108, 1×108, and 2×108 CAR-T groups in sequential order, and will be administered once

Primary Outcome Measures

Name	Time	Method
adverse events	About 1 year	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Secondary Outcome Measures

Name	Time	Method
（Cmax）	About 1 year	Maximum concentration of CD7 CAR-T cells expanded in peripheral blood after drug administration
（Tmax）	About 1 year	Time to maximum concentration
AUC0-28d	About 28 days	Area under the curve at 28 days
AUC0-90d	About 90 days	Area under the curve at 90 days
Disease remission rate	About 90 days	Rate of decline from baseline in the American College of Rheumatology Composite Response Index (ACR-CRISS)

Trial Locations

Locations (1)

PersonGen.Anke Cellular Therapeutice Co. Ltd; 🇨🇳 Hefei, Anhui, China