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临床试验/jRCT2031240200
jRCT2031240200招募中不适用

A Phase 1, First-in-Human, Dose Escalation Study of JNJ-88998377 in Participants with Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)

Janssen Pharmaceutical K.K.0 个研究点目标入组 160 人开始时间: 2024年8月6日最近更新:
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试验速览

阶段
不适用
状态
招募中
入组人数
160
主要终点
Number of Participants with Adverse Events (AEs)
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomized Controlled Trial
干预模型
Single Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 No limit（—）
性别
All

入选标准

  • •Participants have histologically or cytologically confirmed B-cell non-Hodgkin's Lymphoma (NHL) according to the 2022 World Health Organization (WHO) classification with relapsed or refractory disease
  • •Participants have measurable disease or meet all requirements for adequate response assessment as defined by the appropriate disease response criteria at screening
  • •Participants have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • •Participants have a life expectancy of greater than or equal to (>=) 12 weeks
  • •Be willing and able to adhere to the lifestyle restrictions specified in the protocol

排除标准

  • •Participant with active or prior history of B-cell NHL involving the central nervous system (CNS) and leptomeningeal involvement
  • •History of malignancy (other than the disease under study in the cohort to which the participant is assigned) within 1 year prior to the first administration of study treatment as malignancies can interfere with study endpoints
  • •Participant having known allergies, hypersensitivity, or intolerance to the excipients of JNJ-88998377
  • •Participant had major surgery or had significant traumatic injury within 30 days before first dose of study treatment or has not recovered from surgery and must not have major surgery planned during the time the participant is receiving study treatment
  • •Participant received an autologous stem cell transplant less than or equal to (<=) 3 months before the first dose of study treatment

结局指标

主要结局

Number of Participants with Adverse Events (AEs)

时间窗: Upto 3 years 4 months

An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or noninvestigational) product. It does not necessarily have a causal relationship with the investigational product.

Number of Participants with Dose Limiting Toxicity (DLTs)

时间窗: Cycle 1 (21 days)

Number of participant with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematological or hematological toxicity.

次要结局

  • Plasma Concentration of JNJ-88998377(Up to first 12 weeks)
  • Area Under the Plasma Concentration Versus Time Curve During A Dosing Interval (t) At Steady-State of JNJ-88998377(Up to first 12 weeks)
  • Maximum Plasma Concentration (Cmax) of JNJ-88998377(Up to first 12 weeks)
  • Minimum Plasma Drug Concentration (Cmin) of JNJ-88998377(Up to first 12 weeks)
  • Percentage of Participants With Overall Response (OR)(Up to 3 years 4 months)
  • Time to Response (TTR)(From first dose of study treatment until first response of PR or better (up to 3 years and 4 months))
  • Duration of Response (DOR)(From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months))

研究者

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