NCT05932173招募中1 期
An Open Label, Single-site, Dose-escalation Study Aiming to Evaluate the Efficacy and Safety of Anti-CD19 CAR-T Manufactured by OlyCAR Platform(OlyCAR-019) in the Treatment of Relapsed/ Refractory(r/r) B-Cell Malignancies
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of adverse events(AE) after infusion
研究概览
简要总结
It is a single-center, open-labeled, single-arm, non-randomized, investigator-initiated trial aiming to evaluate the efficacy and safety of anti-CD19 CAR-T manufactured by OlyCAR platform (OlyCAR-019) for CD19+ refractory/relapsed B-Cell malignancies.
详细描述
OlyCAR is a novel CAR-T manufacturing system which allows to generate clinical-use CAR-T cells in short time. This study is going to evaluate the feasibility of CAR-T manufactured by OlyCAR platform in the treatment of B-Cell malignancies. The OlyCAR-019 cells will be infused by vein. Subjects will be followed for safety and efficacy up to 12 weeks. For those with a durable remission 12 weeks after infusion, the follow-up will last for at least 12 months for disease control.
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
- 2 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A definite diagnosis of relapsed/refractory B-cell malignancies;
- •Male or female, aged 2-75 years;
- •Confirmed detectable disease；
- •Expected survival time >12 weeks;
- •Eastern cooperative oncology group (ECOG) score is 0-2;
- •Adequate liver , kidney and cardiopulmonary function;
- •Women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up;
- •Willingness to complete the informed consent process and to comply with study procedures and visit schedule.
排除标准
- •Presence of other concurrent active malignancy; People with severe mental disorders;
- •History of any of the following genetic disorders, such as Fanconi anemia, Schu-Day syndrome, Gerstmann syndrome, or any other known bone marrow failure syndrome;
- •Acute GVHD of grade II-IV or extensive chronic GVHD;
- •Grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically prominent heart disease within one year prior to enrollment;
- •The presence of any indwelling catheter or drainage (e.g., percutaneous nephrostomy, indwelling catheter, bile drainage, or pleural/peritoneal/pericardial catheter), except for patients who are permitted to use dedicated central venous catheters;
- •Human immunodeficiency virus (HIV) seropositivity; Hepatitis B surface antigen positive or hepatitis B core antibody positive, and HBV-DNA positive; Patients with hepatitis C (HCV-RNA quantitative test results positive); Or the presence of other serious active viral or bacterial infections or uncontrolled systemic fungal infections; Patients with severe history of allergy or allergic constitution;
- •A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) leading to end-organ damage or requiring systemic immunosuppressive/systemic disease modulating drugs within the past 2 years; Had or is suffering from interstitial lung disease (e.g., pneumonia, pulmonary fibrosis);
- •Had undergone other clinical trials in the 4 weeks prior to participating in this trial;
- •Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan;
- •For patients contraindicated with cyclophosphamide and fludarabine chemotherapy;
- •Subjects requiring systemic corticosteroid therapy (prednisone ≥5mg/ day or equivalent dose of another corticosteroid) or other immunosuppressive agents within 1 month after UCAR-T cell reinfusion, except for adverse events;
- •Receiving donor lymphocyte infusion within 6 weeks before enrollment;
- •Pregnant and lactating women;
- •Subjects with any other condition which the investigator considers unsuitable for inclusion in the study.
结局指标
主要结局
Incidence of adverse events(AE) after infusion
时间窗: Up to 12 months after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
MTD
时间窗: Up to 28 days after infusion
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
次要结局
- Overall Response Rate (ORR)(Up to 3 months after infusion)
- Progression-free survival(PFS)(Up to 3 months after infusion)
研究者
研究点 (1)
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