Clinical Study of CD19 Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of Refractory Systemic Sclerosis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-CD19 CAR-T cells in the treatment of childhood-onset systemic sclerosis

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 18
Healthy Volunteers: f
View:

• Gender unlimited, age ≥5 years;

• Meet the classification criteria for Systemic sclerosis (SSc) as defined by the 2013ACR/EULAR standards;

• any one of the anti-nuclear antibodies or systemic sclerosis specific antibodies positive;

• Improved Rodnan skin score (mRSS) ≥15 points (total 51 points);

• Meet the definition of intractable disease: Glucocorticoids (≥0.5mg/kg/d) and cyclophosphamide, as well as one or more of the following immunomodulators (including antimalarial drugs, azathioprine,motecophanate, methotrexate, leflunomide, tachlimus, cyclosporine, and biologics including rituximab, Beliumab, and titacept, etc.), did not show significant remission of the disease for more than 3 months; Or meet the criteria for rapid disease progression , clinical routine treatment is ineffective, and the benefits outweigh the risks as determined by the investigator and the patient's or guardian's full and informed consent can be considered for inclusion.

• Major organ functions were basically normal: left ventricular ejection fraction (LVEF) ≥55%, no obvious abnormality in electrocardiogram; eGFR≥30ML/min/1.73m2;AST and ALT≤3.0ULN, total bilirubin ≤2.0×ULN; SpO2≥92%, DLCO≥ 40% of predicted value, FVC≥ 50% of predicted value;

• The subject of childbearing age has a negative urine pregnancy test result and agrees to take effective contraceptive measures during the test period until 1 year after the infusion;

• The patient or his/her guardian agrees to participate in the clinical trial and signs an informed consent indicating that he/she understands the purpose and procedure of the clinical trial and is willing to participate in the study

Locations
Other Locations
China
Children's Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Christmas Island
Children's Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Jianhua Mao Children's Hospital, Zhejiang University School of Medicine, PHD
maojh88@zju.edu.cn
13516819071
Time Frame
Start Date: 2024-12-15
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 12
Treatments
Experimental: anti-CD19 CAR-T cells in the treatment of SSc
Related Therapeutic Areas
Sponsors
Leads: The Children's Hospital of Zhejiang University School of Medicine

This content was sourced from clinicaltrials.gov