Actively Recruiting
Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2023-09-28
24
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single arm study to evaluate the efficacy and safety of CD19 targeted CAR-T cells therapy for patients with Refractory Autoimmune Disease
CONDITIONS
Official Title
Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older, male or female
- Diagnosed with one of the following: Systemic Lupus Erythematosus (SLE) by EULAR/ACR 2019 criteria; Sjogren's Syndrome (SS) by 2016 ACR/EULAR criteria; Systemic Scleroderma (SSc) by 2013 ACR/EULAR criteria; Dermatomyositis (DM) by 2017 EULAR/ACR classification plus a positive myositis-specific antibody; Anti-neutrophil cytoplasmic antibody associated vasculitis (ANCA-AAV) including GPA, MPA, or EGPA by 2022 ACR/EULAR criteria
- Disease activity meeting specific scores: SLEDAI ≥8 for SLE; ESSDAI ≥14 for SS; mRSS 10-35 with interstitial pneumonia for SSc; DM diagnosed at least 1 year with specified clinical and laboratory criteria; BVAS ≥15 for ANCA-AAV
- ECOG performance status 0 or 1
- Normal important organ functions including hematology, cardiac, renal, liver, and lung function within specified limits
- Able to undergo simple or intravenous blood collection without contraindications
- Negative pregnancy test if of childbearing potential and agreement to use effective contraception during the study and for 1 year after infusion
- Patient or guardian willing to sign informed consent and understand study purpose and procedures
You will not qualify if you...
- Prior CAR T cell therapy
- Serious heart, liver, lung, blood, or endocrine diseases posing higher risk than benefit as judged by researchers
- Active or uncontrolled infection requiring systemic treatment within 1 week before screening
- Previous hematopoietic stem cell or solid organ transplant (except corneal or hair) or grade 2+ acute graft-versus-host disease within 2 weeks before screening
- Positive for hepatitis B surface antigen or core antibody with elevated HBV DNA, hepatitis C antibody with elevated HCV RNA, HIV antibodies, syphilis, or CMV DNA
- Received live vaccine within 4 weeks before screening
- Positive pregnancy test
- Malignant tumors except certain adequately treated localized cancers
- Participation in other clinical trials within 3 months before screening
- Any other condition deemed unsuitable for participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Actively Recruiting
Research Team
L
Liyun Zhang, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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