A Study of CD19 UCAR-T Cells in Subjects With Autoimmune Diseases (NCT07212322) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study of CD19 UCAR-T Cells in Subjects With Autoimmune Diseases
China24 participantsStarted 2026-01-30
Plain-language summary
The purpose of this study is to assess the safety and efficacy of CD19 UCAR-T cell therapy in Subjects with autoimmune diseases.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Male or female, between 18 and 65 years old;
* Adequate organ functions, defined as follows:
Hematological function \[no transfusion and no use of granulocyte colony-stimulating factor (G-CSF) administration within 2 weeks prior to testing\]: white blood cells (WBC) ≥3.0×10\^9/L, absolute neutrophil count (ANC)≥1.0×10\^9/L, platelet count (PLT)≥50×10\^9/L (ITP subjects are without restrictions), hemoglobin ≥80 g/L.
Coagulation function: international normalized ratio (INR) ≤ 1.5×upper limit of normal value (ULN), and activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3×(ULN), and total bilirubin ≤1.5×ULN. 4)Renal function: serum creatinine ≤1.5×ULN or creatinine clearance (calculated by Cockcroft Gault formula) ≥ 40 ml/min.
Cardiac function: New York Heart Association (NYHA) Grade I or II, and left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography (ECHO), with no pericardial effusion, and no clinically significant abnormalities on12-lead electrocardiogram (ECG).
Pulmonary function: oxygen saturation ≥92% on room air (without supplemental oxygen), no clinically significant pleural effusion.
* Subjects with fertile partners must agree to use effective contraception throughout the treatment period and for 24 months after treatment, and must refrain from donating eggs/sperm for assisted reproduction during this period; Female subjects of childbearin…
What they're measuring
1
Dose Limiting Toxicity
Timeframe: Time Frame: 0~28 day after treatment
2
Frequency of AEs, SAEs
Timeframe: Time Frame: from lymphodepletion to 12 months after treatment
Trial details
NCT IDNCT07212322
SponsorInstitute of Hematology & Blood Diseases Hospital, China