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

PersonGen BioTherapeutics

Status: Not yet enrolling

Conditions: Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria

Treatments: Biological: T cell injection targeting CD7 chimeric antigen receptor

Study type: Interventional

Funder types: Industry

Identifiers

NCT06871644

PG-007-8

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

T cell injection targeting CD7 chimeric antigen receptor

Experimental group

Description:

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

Treatment:

Biological: T cell injection targeting CD7 chimeric antigen receptor