Actively Recruiting
Clinical Study of CD19 Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in Treating Refractory Autoimmune Diseases
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2023-09-28
24
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CD19 targeted CAR-T cell therapy in patients with refractory autoimmune diseases. This study focuses on conditions such as Systemic Lupus Erythematosus, Sjogren's Syndrome, Systemic Scleroderma, Dermatomyositis, and Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis. The goal is to verify the safety and therapeutic potential of this treatment for patients who have not responded to other therapies. The study involves a single infusion of CD19 targeted CAR-T cells administered intravenously. This is a phase 1 clinical trial conducted by Chongqing Precision Biotech Co., Ltd. Participants receive one dose of the CAR-T therapy, and the trial monitors both safety and disease response over time. Treatment effects on autoimmune symptoms and the ability to reduce or stop immunosuppressants and hormones are also evaluated. Participants will undergo regular assessments including safety monitoring for adverse events within the first month after infusion, and evaluations of disease activity over a three-month period. Researchers will measure cell dynamics, pharmacodynamics, and immunological changes up to two years to understand long-term effects. The trial includes clinical evaluations specific to each autoimmune disease and requires informed consent from participants.
CONDITIONS
Brief Title
Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old, male or female
- Diagnosed with one of the following: Systemic Lupus Erythematosus (EULAR/ACR 2019 standard), Sjogren's Syndrome (2016 ACR/EULAR standard), Systemic Scleroderma (2013 ACR/EULAR standard), Dermatomyositis (2017 EULAR/ACR classification and positive myositis-specific antibody), or Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (2022 ACR/EULAR standard)
- Disease activity meets specific scoring criteria for each condition (e.g., SLEDAI ≥8 for lupus, ESSDAI ≥14 for Sjogren's syndrome)
- ECOG performance status of 0 to 1
- Normal function of important organs (hematology, cardiac, renal, liver, and lung function within specified limits)
- Negative pregnancy test and agreement to use effective contraception during the trial and for one year after infusion (for participants of childbearing potential)
- Willingness to provide informed consent and understand the clinical trial procedures
You will not qualify if you...
- Prior treatment with CAR T cell therapy
- Serious diseases of heart, liver, lung, blood system, or endocrine system increasing trial risk
- Active or uncontrolled infection requiring systemic treatment within one week before screening
- Previous hematopoietic stem cell or solid organ transplantation (except corneal or hair), or recent grade 2 or higher acute graft-versus-host disease
- Positive for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus with viral load above normal
- Live vaccine received within four weeks prior to screening
- Positive pregnancy test
- Malignant tumors before screening except certain treated cancers
- Participation in other clinical trials within three months prior to screening
- Any condition the investigator deems unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 months
Participants receive a single infusion of CD19 targeted CAR-T cells administered intravenously to treat refractory autoimmune diseases.
1 infusion visit and multiple follow-up visits during treatment period
Duration - Up to 2 years
Participants are monitored for long-term safety, immune system recovery, and efficacy of the CAR-T therapy after treatment.
Periodic visits during 2 years of follow-up
Trial Site Locations
Total: 1 location
1
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Actively Recruiting
Research Team
L
Liyun Zhang, M.D
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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