UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases

Launched by CHANGZHOU NO.2 PEOPLE'S HOSPITAL · May 11, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called UCAR T-cell therapy for patients who have certain autoimmune diseases, like Systemic Lupus Erythematosus and Myasthenia Gravis, that have not responded well to other treatments. The goal of the study is to see how safe and effective this therapy is for people with these challenging conditions. The trial is currently not recruiting participants, but when it begins, it will be open to adults aged 18 and older, regardless of gender, who have specific health criteria that show they could benefit from this treatment.

To be eligible for the trial, participants must have certain blood cell markers and meet requirements for the function of major organs, such as the heart and kidneys. They will also need to agree to follow the study's instructions and participate in follow-up visits. It's important to note that individuals with severe allergies, active infections, or certain health issues may not be able to join the study. If selected, participants can expect close monitoring throughout the treatment process and will be contributing to research that could help improve care for others with similar autoimmune diseases.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1.Age ≥ 18 years old (inclusive), regardless of gender.
• • 2.Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.
• * 3.Functional requirements for major organs are as follows:
• • 1. Bone marrow function must meet: A. Neutrophil count ≥ 0.5×10 \^ 9/L (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g/L; C. Platelets ≥ 30 × 10 \^ 9/L.
• • 2. Liver function: Alanine aminotransferase (ALT) ≤ 3×ULN (excluding ALT elevation due to inflammatory myopathy), aspartate aminotransferase (AST)≤3×Upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy), TBIL≤1.5×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome);
• • 3. Renal function: creatinine clearance rate (CrCl) ≥ 30ml/minute (calculated by Cockcroft/Gault formula, acute CrCl decrease due to the target disease is excluded; LN is exluded);
• • 4.ECOG score 0-1.
• • 5.Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.
• • 6.Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
• • 7.Subjects with relapsed or refractory autoimmune diseases, Including relapsed or refractory Autoimmune Hemolytic Anemia, relapsed or refractory Systemic Lupus Erythematosus, relapsed or refractory or Progressive Systemic Sclerosis, relapsed or refractory or Progressive Inflammatory Myopathy, relapsed or refractory ANCA-Associated Vasculitis, relapsed or refractory Immunoglobulin-G4 related disease and relapsed or refractory Myasthenia Gravis.
• Exclusion Criteria:
• • 1.Subjects with a history of severe drug allergies or allergic constitutions;
• • 2. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections;
• • 3. Subjects with insufficient cardiac function;
• • 4. Subjects with congenital immunoglobulin deficiencies;
• • 5. Subjects with a history of malignant tumors within the past five years, except for the following conditions: non-melanoma skin cancer, stage I tumors with a low recurrence probability after complete resection, clinically localized prostate cancer after treatment, cervical carcinoma in situ confirmed by biopsy or squamous intraepithelial lesion shown by smear, and stable papillary thyroid carcinoma or follicular thyroid carcinoma.
• • 6. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \>ULN; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing;
• • 7. Subjects with mental illness and severe cognitive dysfunction;
• • 8. Pregnant women or women planning to conceive;
• • 9.Subjects whom the investigator believes have other reasons that make them unsuitable for inclusion in this study.