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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: zhu chen, doctor
- Phone Number: 0551-62283843
- Email: doczchen@ustc.edu.cn
Study Contact Backup
- Name: qian wang, bachelor
- Phone Number: +86 15155193878
- Email: wangqian528@mail.ustc.edu.cn
Study Locations
-
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Anhui
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Hefei, Anhui, China, 230088
- PersonGen.Anke Cellular Therapeutice Co. Ltd
-
Contact:
- Huimin Meng, doctor
- Phone Number: +86-18015580390
- Email: huimin.meng@persongen.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: T cell injection targeting CD7 chimeric antigen receptor
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
adverse events
Time Frame: About 1 year
|
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
|
About 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
（Cmax）
Time Frame: About 1 year
|
Maximum concentration of CD7 CAR-T cells expanded in peripheral blood after drug administration
|
About 1 year
|
|
（Tmax）
Time Frame: About 1 year
|
Time to maximum concentration
|
About 1 year
|
|
AUC0-28d
Time Frame: About 28 days
|
Area under the curve at 28 days
|
About 28 days
|
|
AUC0-90d
Time Frame: About 90 days
|
Area under the curve at 90 days
|
About 90 days
|
|
Disease remission rate
Time Frame: About 90 days
|
Rate of decline from baseline in the American College of Rheumatology Composite Response Index (ACR-CRISS)
|
About 90 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: zhu chen, doctor, The First Hospital Affiliated to the University of Science and Technology of China
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PG-007-8
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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