An Open-label, Multicenter Phase 1/2 Study to Evaluate the Safety and Efficacy of AB-2100 in Patients With Recurrent Advanced or Metastatic Clear-cell Renal Cell Carcinoma (ccRCC)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 37
- 试验地点
- 9
- 主要终点
- Phase 1 (Dose escalation): incidence of adverse events
研究概览
简要总结
This is a multi-center, open-label phase 1/2 trial evaluating the safety and efficacy of AB-2100 cell product. The study may enroll approximately 60 patients in phase 1 and approximately 70 patients in phase 2.
详细描述
This study is intended for the patients who have been diagnosed with clear-cell renal cell carcinoma that either came back or did not improve after treatment with a checkpoint inhibitor and a VEGF inhibitor. The purpose of this study is to test the safety and efficacy of AB-2100 cells in patients with renal cell carcinoma. This treatment has not been approved by the Food and Drug Administration.
The goal of this study is to determine the maximum tolerated dose of the AB-2100 cells. T cells are part of the immune system that protect the body from infection and may help fight cancer. The T cells given in this study will come from the patient and will have a genetic circuit/logic gate put in them that makes them able to recognize prostate-specific membrane antigen (PSMA) and carbonic anhydrase 9 (CA9), 2 proteins found on tumor cells. These logic-gated T cells may help the body's immune system identify and kill cancer cells while sparing normal healthy tissues from toxicity.
The AB-2100 cells are given as a single intravenous infusion. Patients may be assigned to receive conditioning chemotherapy prior to the infusion
After completion of study treatment, patients are followed with serial measurements of safety, tolerability and response.
This is a research study to obtain new information that may help people in the future.
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
- •Advanced or metastatic clear-cell renal cell carcinoma
- •Must have received an immune checkpoint inhibitor and a VEGF-targeted therapy in the advanced or metastatic setting. Must have evidence of progression on or after the last treatment regimen or discontinued treatment for unacceptable toxicity.
- •Adequate organ function as per protocol definitions.
- •Eastern Cooperative Oncology Group (ECOG) performance status score 0 or
- •Measurable disease at time of enrollment as per protocol definitions.
- •Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after AB-2100 infusion.
排除标准
- •Any prior systemic RCC therapy within 14 days of time of cell collection (interval of 28 days will be required if the last immediate treatment contained an antibody-based agent).
- •Systemic anti-cancer therapy within 14 days of starting of conditioning chemotherapy (interval of 28 days will be required if the last immediate treatment contained an antibody-based agent)
- •Investigational cellular therapies within 8 weeks prior to start of conditioning chemotherapy
- •Prior treatment with anti-CA9 therapies
- •Myocardial infarction or unstable angina within 6 months prior to screening
- •Pleural effusion that requires drainage for symptom management within 28 days of screening.
- •Active autoimmune disease requiring immunosuppressive therapy or uncontrolled with treatment.
- •Untreated brain metastasis.
- •Subjects unwilling to participate in an extended safety monitoring period.
研究组 & 干预措施
AB-2100
Patients receive a single dose of AB-2100 intravenously on day 0. Patients may be assigned to receive conditioning chemotherapy prior to the infusion.
干预措施: AB-2100 (Biological)
结局指标
主要结局
Phase 1 (Dose escalation): incidence of adverse events
时间窗: From AB-2100 infusion up to 21 days post infusion
Defined as dose-limiting toxicities based on a 3+3 dose escalation study design
Phase 2 (Cohort expansion): Objective response rate (ORR)
时间窗: From AB-2100 infusion up to 24 months post-infusion
ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have achieved a best overall response of CR or PR according to RECIST v1.1
次要结局
未报告次要终点