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

NCT ID: NCT06871644

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-18
• Study Completion Date: 2027-03-31

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.

Conditions

Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

T cell injection targeting CD7 chimeric antigen receptor

Intervention Type: BIOLOGICAL

Subjects who sign the informed consent form and meet the inclusion/exclusion criteria will be entered into the 0.25×108, 1×108 and 2×108 CAR-T groups, in order of priority, and will be administered 1 dose of

Interventions

T cell injection targeting CD7 chimeric antigen receptor

Subjects who sign the informed consent form and meet the inclusion/exclusion criteria will be entered into the 0.25×108, 1×108 and 2×108 CAR-T groups, in order of priority, and will be administered 1 dose of

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

zhu chen, doctor

Role: PRINCIPAL_INVESTIGATOR

The First Hospital Affiliated to the University of Science and Technology of China

Locations

PersonGen.Anke Cellular Therapeutice Co. Ltd

Hefei, Anhui, China

Countries

China

Central Contacts

zhu chen, doctor

Role: CONTACT

doczchen@ustc.edu.cn

0551-62283843

qian wang, bachelor

Role: CONTACT

wangqian528@mail.ustc.edu.cn

+86 15155193878

Facility Contacts

Huimin Meng, doctor

Role: primary

huimin.meng@persongen.com

+86-18015580390

Other Identifiers

PG-007-8

Identifier Type: -

Identifier Source: org_study_id