Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria
Conditions
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.
Interventions
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
Sponsors
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
CD7 CAR-T cell therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | About 1 year | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| （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) |
Countries
China
Contacts
Primary Contactzhu chen, doctor
Backup Contactqian wang, bachelor
Outcome results
None listed