Clinical trial NCT06871644: Clinical Study of CD7 CAR-T Cells for Relapsed/refractory Autoimmune Diseases
Official title: CD7CAR-T Cell Therapy As a Single-Arm, Open-Label, Single-Center Investigator-Initiated Early-Stage Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria
Lead sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: CD7 CAR-T cell therapy
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: adverse events
timeFrame: About 1 year
Secondary outcomes:
measure: （Cmax）
timeFrame: About 1 year
measure: （Tmax）
timeFrame: About 1 year
measure: AUC0-28d
timeFrame: About 28 days
measure: AUC0-90d
timeFrame: About 90 days
measure: Disease remission rate
timeFrame: About 90 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: PersonGen.Anke Cellular Therapeutice Co. Ltd
state: Anhui
Study officials:
affiliation: The First Hospital Affiliated to the University of Science and Technology of China
name: zhu chen, doctor
role: PRINCIPAL_INVESTIGATOR
References: