A Phase 1/2 Clinical Study Evaluating MDX2003 in Participants With Relapsed, Progressive, or Refractory B-Cell Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Part A only- Identify the Maximum Tolerated Dose (MTD) for expansion for further development of MDX2003
研究概览
简要总结
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Participant must be ≥ 18 years of age.
- •Participant has a confirmed diagnosis of large B-cell lymphoma (including DLBCL, high-grade B-cell lymphoma [HGBCL], primary mediastinal B-cell lymphoma [PMBCL], etc), FL, MCL, marginal zone lymphoma, transformation of indolent B-cell lymphoma, or lymphoplasmacytic lymphoma, including Waldenstrom macroglobulinemia.
- •Participant has relapsed or progressed on at least 2 prior lines of therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •All participants must have measurable disease via computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)-CT.
- •Documented CD19 or CD20 positivity of their B-cell neoplasm based on any representative pathology report from the past 3 months.
- •Adequate hematologic, hepatic and renal function.
- •All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Capable of giving signed informed consent.
排除标准
- •Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
- •Unresolved toxicities from previous anticancer therapy.
- •Primary central nervous system (CNS) lymphoma or known CNS involvement with lymphoma.
- •Active medical condition requiring chronic systemic steroid use (>10 mg/day prednisone or equivalent of >140 mg over the last 14 days) or immunosuppressive therapy, within 6 months prior to the first dose of MDX
- •Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infection requiring intravenous treatment.
- •Participant has a history of allogenic tissue or solid organ transplant, with the exception of corneal transplants.
- •Known hypersensitivity to allopurinol or rasburicase.
- •Participant has a seizure disorder requiring therapy at the time of screening (such as steroids or anti-epileptics).
- •Participant is not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.
研究组 & 干预措施
Dose Escalation- Part A
Participants with B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion.
干预措施: MDX2003 (Drug)
Indication Optimization- Part B
Participants with select B-cell malignancies will receive MDX2003 as an intravenous (IV) infusion.
干预措施: MDX2003 (Drug)
结局指标
主要结局
Part A only- Identify the Maximum Tolerated Dose (MTD) for expansion for further development of MDX2003
时间窗: 28 days
Maximum Tolerated Dose is determined following the evaluation of MDX2003 safety, including the incidences of dose-limiting toxicities (DLTs), MDX2003 anti-tumor activity, and MDX2003 pharmacokinetics/pharmacodynamics.
All Study Parts: Adverse Events (AEs)
时间窗: Baseline until 90 days after the participant has the last dose of MDX2003
Incidence and severity of adverse events (AEs) and serious AEs (SAEs), including changes in clinical laboratory parameters, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria, including changes in clinical laboratory parameters.
Part B only- Assess the preliminary anti-lymphoma activity of MDX2003
时间窗: From date of enrollment until the end of treatment, up to approximately 6 months
Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per Lugano Classification.
次要结局
- All Study Parts: Evaluation of MDX2003 immunogenicity(6 months)
- All Study Parts: Measure of terminal half-life (t1/2) of MDX2003(6 months)
- All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2003(6 months)
- All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2003(6 months)
- All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2003(6 months)
- All Study Parts: Measure of volume of distribution (Vd) of MDX2003(6 months)
- All Study Parts: Measure of system clearance of MDX2003(6 months)