NCT05806099招募中1 期
A Phase I/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS303 in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Beijing Mabworks Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2023年6月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Phase I：Incidence of Dose Limiting Toxicities (DLTs)
研究概览
简要总结
This is a Phase I/Ⅱ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a novel T-Cell bispecific (TCB), MBS303, administered by intravenous (IV) infusion in participants with relapsed or refractory B-cell NHL. This entry-to-human study consists of 2 parts: a dose escalation part (Phase I) and an expansion part (Phase Ⅱ)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide written informed consent and to comply with the study protocol.
- •Adult patients, ≥18 years of age;
- •CD20+ B-cell Non-Hodgkin Lymphoma who have relapsed after or failed to respond to at least one prior treatment regimen with an anti-CD20 monoclonal antibody and for whom there is no available therapy expected to improve survival;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Life expectancy ≥3 months;
- •Measurable disease, defined as at lease one bi-dimensionally measurable nodal lesion, defined as >1.5 cm in its longest dimension, or at least one bi-dimensionally measureable extranodal lesion, defined as >1.0 cm in its longest dimension
- •Adequate hematologic, hepatic, and renal function.
排除标准
- •Chronic lymphoblastic leukemia, Burkitt lymphoma or lymphoplasmacytic lymphom;
- •History of central nervous system (CNS) lymphoma or other CNS disease;
- •Participants with known active infection, including bacterial, viral, parasite, mycobacterial, or other infections (excluding nail bed fungal infections);
- •Surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, tumor embolization, or other antitumor therapy within 28 days prior to the first MBS303;
- •Active or suspected autoimmune diseases;
- •Known severe allergic reaction or/and infusion reaction to monoclonal antibody;
- •Evidence of significant, uncontrolled concomitant disease;
- •Major surgery within 28 days prior to the first MBS303 administration or expected to undergo major surgery during the study treatment;
- •History of another invasive malignant tumors in past 3 years;
- •Participant with history of confirmed progressive multifocal leukoencephalopathy (PML);
- •Severe hemorrhagic diseases such as hemophilia A, hemophilia B, vascular hemophilia, or spontaneous bleeding requiring blood transfusion or other medical intervention;
- •Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal HBV DNA or HCV RNA);
- •Pregnant or lactating women; Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) while participating in the study; 2) for at least 12 months after discontinuation of all study treatments.
研究组 & 干预措施
MBS303
Experimental
干预措施: MBS303 (Drug)
结局指标
主要结局
Phase I：Incidence of Dose Limiting Toxicities (DLTs)
时间窗: From Baseline up to 3 weeks
Phase I：Percentage of Participants with Adverse Events (AEs)
时间窗: From Baseline up to approximately 13 months
Percentage of Participants with AEs and SAEs Assessed by NCI CTCAE v5.0
Phase Ⅱ ：Antitumor activity as measured by the objective response rate (ORR)
时间窗: Up to approximately 2 years
Phase I：Maximum Tolerated Dose (MTD) of MBS303
时间窗: From Baseline up to 3 weeks
Phase I：Recommended Phase Ⅱ Dose (RP2D) of MBS303
时间窗: From Baseline up to 4 years
次要结局
- Phase I and Ⅱ ：Efficacy: Progression-Free Survival (PFS) of MBS303 as Assessed Using Standard Criteria for NHL(Up to approximately 2 years)
- Phase I :Efficacy: ORR(Up to approximately 2 years)
- Phase I and Ⅱ ：Pharmacokinetics: AUC(up to approximately 1 year)
- Phase I and Ⅱ ：Pharmacokinetics: t1/2(up to approximately 1 year)
- Phase I and Ⅱ ：Pharmacokinetics: CL(up to approximately 1 year)
- Phase I and Ⅱ ：Efficacy: Complete Response Rate (CRR) of MBS303 as Assessed Using Standard Criteria for NHL(Up to approximately 2 years)
- Phase I and Ⅱ ：Efficacy: Duration of Response (DOR) of MBS303 as Assessed Using Standard Criteria for NHL(Up to approximately 2 years)
- Phase I and Ⅱ ：Pharmacokinetics: Vd(up to approximately 1 year)
- Phase I and Ⅱ ：Efficacy: Overall Survival (OS) of MBS303(Up to approximately 2 years)
- Phase I and Ⅱ ：Immunogenicity: Anti-Drug Antibodies (ADA) to MBS303(Up to approximately 1 year)
研究者
研究点 (1)
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