NCT07819188尚未招募1 期
A Phase Ib/II Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of SCTB35 in Combination With SCTB41, With or Without Concomitant Chemotherapy, in Patients With Non-Hodgkin's Lymphoma.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Phase 1: dose limited toxicity (DLT)
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of SCTB35 and SCTB41 With or Without Chemotherapy in non-Hodgkin's lymphoma patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 80 years (inclusive) at the time of informed consent
- •Histologically or cytologically confirmed B cell neoplasm.
- •Phase 1: Relapsed or refractory disease after at least two prior systemic therapy.
- •Measurable or evaluable disease at enrollment.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Adequate organ and bone marrow function
- •Life expectancy of ≥ 3 months
排除标准
- •Prior treatment with bispecific antibodies targeting both CD20 and CD3
- •Prior treatment with antibodies targeting both PD-1/PD-L1, PD-(L)1/VEGF(R) or PD-(L)1/TGF-β
- •Eligible for high dose chemotherapy followed by hematopoietic stem cell transplantation (HSCT)
- •Known central nervous system (CNS) involvement by lymphoma
- •Known any major episode of active infection requiring treatment with systemic antibiotics within 2 weeks
- •Chemotherapy and other non-investigational antineoplastic agents within 4 weeks or 5 half-lives (whichever is shorter) prior to first SCTB35 administration
研究组 & 干预措施
SCTB35 Plus SCTB41
Experimental
干预措施: SCTB35 injection (Drug)
SCTB35 Plus SCTB41
Experimental
干预措施: SCTB41 (Drug)
结局指标
主要结局
Phase 1: dose limited toxicity (DLT)
时间窗: Within 28 days of the first administration
To determine the maximum tolerated dose (MTD) and/or RP2D to be studied in the dose-expansion part
Phase 2: Percentage of Participants Achieving Objective Response Rate (ORR)
时间窗: Up to approximately 3 years
ORR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria
次要结局
- Overall Survival (OS)(Up to approximately 3 years)
- Progression free survival (PFS)(Up to approximately 3 years)
- Percentage of Participants Achieving CR(Up to approximately 3 years)
- Duration of Response (DOR)(Up to approximately 3 years)
- Duration of Complete Response (DOCR)(Up to approximately 3 years)
- Time to Response (TTR)(Up to approximately 3 years)
- Time to Complete Response (TTCR)(Up to approximately 3 years)
- Adverse Events(Up to approximately 3 years)
- Blood Concentrations of SCTB35 and SCTB41(Up to approximately 6 months)
- Anti-drug Antibodies of SCTB35 and SCTB41(Up to approximately 3 years)
研究者
研究点 (1)
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