A Phase I Clinical Study Evaluating the Safety and Efficacy of SCTC21C in Participants With CD38+ Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Treatment-emergent adverse events (TEAEs) and serious adverse event (SAE)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of SCTC21C in patients with CD38+ hematologic malignancies
详细描述
This is a multicenter, open-label, phase I study aimed to evaluate the safety, tolerability, pharmacokinetics（PK）, Pharmacodynamics（PD）, preliminary anti-tumor activity and immunogenicity of SCTC21C in patients with relapsed or refractory CD38+ hematologic malignancies.The study includes Dose-finding stage and Dose-expansion stage. In Dose-finding stage, participants will be assigned to receive sequentially higher doses of SCTC21C ranging from 0.01 to 960mg. In Dose-expansion stage, total of at least 20 participants will be randomly assigned to receive two different doses of SCTC21C at a ratio of 1:1.All participants will receive the treatment until disease progression or unacceptable drug-related adverse events.
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
- •Male or female aged ≥ 18 years old when signing ICF, weight ≥ 40 kg, ≤ 90 kg
- •Relapsed or refractory CD38+（confirmed by immunohistochemistry or flow cytometry） hematologic malignancies
- •Standard therapies failed or are unavailable or intolerant
- •Participants have at least one of the measurable lesions
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Life expectancy ≥3 months
- •Participants with basically normal liver, kidney and heart functions
- •Hematology requirements: platelet≥75x10^9 /L,absolute neutrophil counts ≥ 1.0x10^9 /L, hemoglobin ≥ 8.0 g/dL
- •Women of childbearing potential (must have a negative blood pregnancy test within 7 days before the first dose) or male participants must use a highly effective method of contraception from signed ICF to 5 months after the last dose.All participants are prohibited from donating sperms or ova during the study period and 5 months after the last dose
排除标准
- •A history of allergic reactions to any SCTC21C injection or any excipients, or Participants with a history of severe drug allergy
- •Participants who have other antineoplastic drug (except hormones) or radiotherapy within four weeks prior to the first dose of study drug, or the participants who have received immunotherapy or anti-CD38 monoclonal antibody within 6 months
- •Adverse events from the previous treatment have not resolved to ≤ Grade 1
- •Participants with prior immunotherapy and Grade ≥ 3 cytokine release syndrome(CRS)
- •Central nervous system involvement
- •Participants with positive Human immunodeficiency virus (HIV) antibody
- •HBsAg positive with HBV-DNA titer higher than the lower limit of the test value of the research center, or HCV antibody positive with HCV-RNA titer higher than the lower limit of the test value of the research center
- •Active infections that require systemic treatment within 1 week prior to the first dose
- •History of additional malignant tumor or active autoimmune diseases,or participants with other serious medical conditions
- •Participants underwent major surgery within 4 weeks prior to the first dose, or had a surgical schedule during the study period
- •History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation,or history of autologous hematopoietic stem cell transplantation within 6 months prior to screening
- •Participants with significant digestive system dysfunction that may affect drug intake, transport and absorption
- •Participants who have received live vaccines within 30 days prior to the first dose of study drug
- •Participants with mental disorders or poor compliance
- •Female participants who are breastfeeding
- •The Investigator determined that the participant is ineligible for the study for other reasons
研究组 & 干预措施
Dose-finding and dose-expansion
Dose-finding stage: The dose escalation in this study is pre-defined in nine dose groups. The dose escalation starts with 0.01mg and proceeds from low to high doses.
Dose-expansion stage: Patients will be randomly assigned to receive different doses of SCTC21C at a ratio of 1:1. Doses of SCTC21C will be determined based on the data obtained in the Dose-finding stage.
干预措施: SCTC21C (Biological)
结局指标
主要结局
Treatment-emergent adverse events (TEAEs) and serious adverse event (SAE)
时间窗: From the initiation of the first dose to the 45 days after the last dose
To identify the incidence of TEAEs and SAE
The incidence of dose limiting toxicities （dose-finding stage）
时间窗: Cycle 1 (28 days)
To identify the DLTs
次要结局
- Objective response rate (ORR)(Throughout the study treatment,an average of 1 year)