Allogeneic CD19-targeting T cells for treatment-refractory systemic lupus erythematosus: a phase 1 trial.
Xiaobing Wang, Yi Zhang, Huimin Wang...
https://pubmed.ncbi.nlm.nih.gov/40866583Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06379646
An Exploratory Clinical Study of the Safety and Efficacy of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
Led by China Immunotech (Beijing) Biotechnology Co., Ltd. · Updated on 2024-08-29
6
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
China Immunotech (Beijing) Biotechnology Co., Ltd.
Lead Sponsor
S
Shanghai Changzheng Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, initial effectiveness, and pharmacokinetic and pharmacodynamic characteristics of YTS109 cell injections in people with recurrent or difficult-to-treat autoimmune diseases. This exploratory clinical trial focuses on patients who have conditions such as systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, inflammatory myopathy, ANCA-associated vasculitis, and antiphospholipid syndrome. The study aims to better understand how YTS109 cells behave and impact these diseases when conventional treatments have not worked. Participants will receive a single injection of YTS109 cells at a dose of 3 million STAR+ T cells per kilogram of body weight. The treatment is administered once during the study. The trial does not include a placebo or comparison group and is conducted without masking or blinding. The study covers a treatment assessment period of 3 months, with additional evaluations extending up to 6 months for some measures. During the study, participants will undergo safety monitoring for treatment-emergent adverse events over 3 months. Researchers will measure efficacy outcomes for each autoimmune condition at 3 and 6 months. Blood tests will assess YTS109 cell levels and pharmacodynamics at 3 and 6 months as well. Participants will be closely followed for organ function, immune responses, and disease activity, with a total involvement period spanning up to 6 months after treatment.
CONDITIONS
Brief Title
An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age ranges from 18 to 65 years old, any gender
- Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry
- Adequate bone marrow function with neutrophil count 651x10^9/L and hemoglobin 6560g/L
- Liver function within limits: ALT 653x upper limit of normal (ULN), AST 653x ULN, total bilirubin 651.5x ULN
- Renal function with creatinine clearance 6530 ml/minute
- Coagulation function with INR and prothrombin time 651.5x ULN
- Good heart function with stable hemodynamics
- For women of childbearing potential: negative serum HCG test within 7 days before enrollment and not breastfeeding
- Use of medically approved contraception or abstinence during treatment and for 6 months after
- Voluntary participation with signed informed consent and willingness to comply with follow-up
- Meet specific disease criteria for recurrent/refractory systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, inflammatory myopathy, ANCA-associated vasculitis, or antiphospholipid syndrome as detailed in the protocol
You will not qualify if you...
- Severe drug allergy or allergic constitution
- Active or uncontrolled fungal, bacterial, viral or other infections
- Central nervous system disorders excluding specified pre-existing conditions
- Cardiac dysfunction
- Congenital immunoglobulin deficiency
- History of malignant tumor within the past 5 years
- End-stage renal failure
- Positive for hepatitis B, hepatitis C, HIV, or syphilis infection as specified
- Mental illness or severe cognitive impairment
- Participation in other clinical trials within 3 months before enrollment
- Recent use of immunosuppressants or biologics within defined periods
- Pregnancy or planning to become pregnant
- Any other conditions judged by investigators to prevent study participation
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 months for safety and initial efficacy assessments
Participants receive a single injection of YTS109 cells to treat their recurrent or refractory autoimmune disease.
Multiple visits during the 3 months for safety and efficacy measurements
Follow-up
Duration - Up to 6 months after treatment
Participants continue to be monitored for efficacy and pharmacokinetic/pharmacodynamic outcomes.
Visits at 3 and 6 months post-treatment for additional assessments
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
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Research Team
H
Huji Xu
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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