NCT07274059招募中1 期
Clinical Study on the Safety and Efficacy of Allogeneic, Umbilical Cord Blood Derived CAR T-cell Therapy for Refractory Systemic Lupus Erythematosus
Chengdu Ucello Biotechnology Co., Ltd.2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年3月26日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- the incidence rate of Dose limited toxicity (DLTs)
研究概览
简要总结
The purpose of this clinical trial is to learn if allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) targeting CD19 and BCMA works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the UCAR-T cell product.
详细描述
- The main questions it aims to answer are: What CAR-T-related adverse events (AEs) occur within 3 months after the UCAR-T cell infusion? Which dose level is the optimal biological dose (OBD)? What are the changes of disease activity status, proportion of patients achieving DORIS remission, percentage of participants achieving maintenance of drug-free DORIS remission, proportion of patients achieving SRI-4 remission, percentage of participants achieving maintenance of LLDAS?
- Participants will may receive lymphodepletion chemotherapy (fludarabine plus cyclophosphamide) if clinically needed. If lymphodepletion chemotherapy is administered, rest for 2 days on Day -2 and Day -1. Receive UCAR-T cells infusion on Day 0. Then be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days. Visit the clinic at Day 14, Day 28, month 3, month 6, month 9, month 12, month 18 and month 24 after UCAR-T cells infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 75 years (inclusive), regardless of gender.
- •Definitive diagnosis of systemic lupus erythematosus (SLE) meeting the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE
- •Treatment refractory: failed ≥ 2 conventional SLE treatments for at least 3 months.
- •Disease activity assessed by SELENA-SLEDAI score ≥ 6 with at least one British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation) or two Class B (moderate manifestation) organ scores (or both); OR SELENA-SLEDAI score ≥
- •Adequate function of major organs as follows:
- •Bone marrow function: a. Neutrophil count ≥ 1 × 10⁹/L (no colony-stimulating factor therapy within 2 weeks prior to testing, excluding neutropenia caused by SLE); b. Hemoglobin ≥ 60 g/L.
- •Liver function: Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN) (excluding ALT elevation caused by SLE); Aspartate aminotransferase (AST) ≤ 3 × ULN (excluding AST elevation caused by SLE); Total bilirubin (TBIL) ≤ 1.5 × ULN (excluding TBIL elevation caused by SLE).
- •Renal function: Creatinine clearance rate (CrCl) ≥ 30 mL/minute (calculated by Cockcroft/Gault formula, excluding CrCl reduction caused by SLE).
- •Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; Prothrombin time (PT) ≤ 1.5 × ULN.
- •Cardiac function: Hemodynamically stable.
- •Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must use medically approved contraceptive methods or abstain from sexual intercourse during the study treatment period and for at least 6 months after the end of study treatment. Female subjects of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to study enrollment and must not be breastfeeding.
- •Voluntarily agrees to participate in the clinical study, signs the informed consent form (ICF), and demonstrates good compliance with study procedures and follow-up.
排除标准
- •History of severe drug allergies or atopic diathesis.
- •Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.
- •Cardiac function insufficient to tolerate the study treatment.
- •Congenital immunoglobulin deficiency.
- •History of malignant tumors within the past 5 years.
- •End-stage renal failure.
- •Positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the lower limit of detection; positive for hepatitis C virus (HCV) antibody with positive peripheral blood HCV RNA; positive for human immunodeficiency virus (HIV) antibody; positive syphilis test.
- •History of mental illness or severe cognitive impairment.
- •Use of disease-modifying immunosuppressive agents within 5 half-lives or biological agents within 4 weeks prior to enrollment.
- •Pregnant females or females planning to become pregnant.
- •Other conditions deemed by the investigator to preclude study participation.
研究组 & 干预措施
UCAR-T cells treatment
Experimental
干预措施: allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA (Drug)
结局指标
主要结局
the incidence rate of Dose limited toxicity (DLTs)
时间窗: Up to 28 days after infusion
Dose limited toxicity(DLT) was defined as the occurrence of any of the following adverse events within 28 days of the infusion of UCAR-T cells.
the rate of adverse events
时间窗: up to 2 months after UCAR-T injection
The number, frequency, severity, and laboratory findings of all treatment-related adverse events/serious adverse events are included.
次要结局
- Percentage of participants achieving maintenance of drug-free DORIS remission(up to 2 years after UCAR-T injection)
- Proportion of patients achieving SRI-4 remission(up to 2 years after UCAR-T injection)
- the changes of SELENA-SLEDAI score(up to 2 years after UCAR-T injection)
- Percentage of participants achieving maintenance of LLDAS(up to 2 years after UCAR-T injection)
- the changes of BILANG 2004 score(up to 2 years after UCAR-T injection)
- the changes of Physician's Global Assessment (PGA)(up to 2 years after UCAR-T injection)
- Proportion of patients achieving DORIS remission(up to 2 years after UCAR-T injection)
研究者
研究点 (2)
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