A Study of CAR-T Cells Targeting Autoimmune Diseases
1 other identifier
interventional
12
1 country
1
Brief Summary
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in patients with autoimmune disease.
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 Nov 2024
Longer than P75 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
October 25, 2024
CompletedFirst Posted
Study publicly available on registry
October 28, 2024
CompletedStudy Start
First participant enrolled
November 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 20, 2028
October 28, 2024
October 1, 2024
3.4 years
October 25, 2024
October 25, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Dose Limiting Toxicity
0~28 day after treatment
Frequency of AEs, SAEs
0 day to 24 months after treatment
Study Arms (1)
CAR-T treatment
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female, between 18 and 56 years old;
- Diagnosed with Autoimmune Diseases；
- Good organ functions;
- Voluntary participates this trial and can comprehend and sign ICF.
You may not qualify if:
- Had or has active malignancy;
- Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
- Combined with other autoimmune disease that needs treatment;
- Pregnant or lactating women;
- Has other factors that deemed not suitable by investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Gaobo Boren Hospital
Beijing, 100070, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yajing Zhang, MD/PhD
Beijing Gaobo Boren Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2024
First Posted
October 28, 2024
Study Start
November 15, 2024
Primary Completion (Estimated)
April 20, 2028
Study Completion (Estimated)
June 20, 2028
Last Updated
October 28, 2024
Record last verified: 2024-10