Clinical Study of CD7 CAR-T Cells for Relapsed/refractory Autoimmune Diseases
CD7CAR-T Cell Therapy As a Single-Arm, Open-Label, Single-Center Investigator-Initiated Early-Stage Clinical Study
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2025
CompletedFirst Posted
Study publicly available on registry
March 12, 2025
CompletedStudy Start
First participant enrolled
March 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
ExpectedMarch 12, 2025
March 1, 2025
1 year
February 27, 2025
March 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
About 1 year
Secondary Outcomes (5)
（Cmax）
About 1 year
（Tmax）
About 1 year
AUC0-28d
About 28 days
AUC0-90d
About 90 days
Disease remission rate
About 90 days
Study Arms (1)
T cell injection targeting CD7 chimeric antigen receptor
EXPERIMENTALCD7 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
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
Eligibility Criteria
You may qualify if:
- \- 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
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PersonGen.Anke Cellular Therapeutice Co. Ltd
Hefei, Anhui, 230088, China
Study Officials
- PRINCIPAL INVESTIGATOR
zhu chen, doctor
The First Hospital Affiliated to the University of Science and Technology of China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2025
First Posted
March 12, 2025
Study Start
March 18, 2025
Primary Completion
March 31, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
March 12, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
Research details