Clinical Study of CD7 CAR-T Cells for Relapsed/refractory Autoimmune Diseases
NCT06871644 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-03-12
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.
Conditions
- Systemic Sclerosis - 2013 ACR/EULAR Classification Criteria
Interventions
- BIOLOGICAL
-
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
Sponsors & Collaborators
-
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
lead INDUSTRY
Principal Investigators
-
zhu chen, doctor · The First Hospital Affiliated to the University of Science and Technology of China
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-18
- Primary Completion
- 2026-03-31
- Completion
- 2027-03-31
Countries
- China
Study Locations
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