Actively Recruiting
Clinical Study of CD19 Targeted Universal Chimeric Antigen Receptor T Lymphocytes (UCAR-T) for the Treatment of Refractory Juvenile Dermatomyositis (RJDM)
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2024-11-13
18
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, single-arm, dose-escalation trial primarily designed to evaluate the safety and efficacy of a universal CAR-T cell therapy targeting CD19 in the treatment of patients with RJDM. Additionally, the study aims to characterize its pharmacokinetic and pharmacodynamic properties, explore its role in immune system reconstitution, and assess long-term survival benefits.
CONDITIONS
Official Title
Clinical Study of CD19 Targeted Universal Chimeric Antigen Receptor T Lymphocytes (UCAR-T) for the Treatment of Refractory Juvenile Dermatomyositis (RJDM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 5 years or older
- Diagnosis of juvenile dermatomyositis (JDM) according to Bohan and Peter criteria
- Classified as refractory juvenile dermatomyositis (RJDM) with intolerance or inadequate response to glucocorticoids and at least two immunosuppressants, and meeting additional disease activity or organ involvement conditions
- Patients with immune-mediated necrotizing myopathy positive for SRP or HMGCR antibodies meeting RJDM criteria
- Normal basic function of important organs including cardiac function (LVEF 65%), renal function (eGFR 65 mL/min/1.73m2), liver function (AST and ALT 64 3.0 ULN, total bilirubin 64 2.0x ULN), and pulmonary function (SpO2 65 92%)
- Female subjects of childbearing age must have a negative urine pregnancy test and agree to use effective contraception during the trial and for one year after infusion
- Patient or guardian consents to participate and understands the study procedures
You will not qualify if you...
- Prior CAR-T cell therapy (unless safety risks are judged eliminated by investigator)
- Primary immunodeficiency or severe secondary immunodeficiency not corrected
- Severe, active, or uncontrolled infections including active tuberculosis and active viral hepatitis
- Active malignant diseases or confirmed malignancies before screening (except cured cutaneous basal cell carcinoma)
- Congenital heart disease, recent acute myocardial infarction within 6 months, severe arrhythmias, severe myocarditis, or unstable vital signs requiring vasopressors
- Other diseases requiring long-term glucocorticoids or immunosuppressants
- Solid organ or hematopoietic stem cell transplantation within 3 months before screening or acute graft-versus-host disease grade 2 or higher within 2 weeks before screening
- Positive tests for hepatitis B surface antigen, hepatitis C virus antibody, HIV antibody, or syphilis
- Receipt of live vaccines within 4 weeks before screening
- Positive blood pregnancy test
- Participation in other clinical trials within 3 months before enrollment
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital Zhejiang University School of Medicine, Hangzhou, zhejiang
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
L
Lu Mei ping, 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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