A Phase 1a/1b Study of 27T51, an Anti-MUC16 CAR T Cell Drug Product Administered Alone or in Combination for Participants With Recurrent or Refractory Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 9
- 主要终点
- Incidence of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This study is researching an experimental CAR T cell therapy called 27T51, referred to as study drug. The study drug is a MUC16 targeting immune cell therapy focused on adult female participants with recurrent or difficult to treat epithelial ovarian, primary peritoneal or fallopian tube cancer.
This study has two (2) major parts:
Phase 1a Dose Escalation and Phase 1b Dose Expansion. The aim of the dose escalation part will be to test the safety of 27T51 in a small number of participants to find the highest dose given to humans without unacceptable side effects. The aim of the dose expansion part will be to test 27T51 at the established dose level(s) from the dose escalation part and may include other medications given in combination with 27T51.
Information collected from this study will help researchers understand more fully whether this immune cell therapy, also known as CAR T cell therapy, can be safely used to treat solid tumors such as ovarian cancer.
详细描述
Former Sponsor 2seventy bio
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- •Histological diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube cancer according to World of Health Organization (WHO) 2020 classification
- •Recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer, as described in the protocol
- •Serum cancer antigen (CA) 125 ≥ 2 × upper limit of normal (ULN) as assessed at the local lab by a 510(k) cleared test at screening
- •Participants must have at least 1 measurable tumor lesion as defined by the response evaluation criteria in solid tumors (RECIST) 1.
- •Expected survival ≥ 3 months
排除标准
- •Inadequate cardiovascular, renal and hepatic function, as described in the protocol
- •Absolute lymphocyte count (ALC) < 100 cells/μL at time of leukapheresis
- •History of Grade ≥ 2 hemorrhage within 30 days, or inadequate coagulation parameters, as described in the protocol
- •Known history or presence of clinically relevant central nervous system (CNS) pathology, as described in the protocol
- •Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune related adverse events (AEs)
- •Treatment with any cellular or gene therapy
- •Note: Other protocol-defined Inclusion/Exclusion criteria apply
研究组 & 干预措施
Dose Escalation
27T51 monotherapy
干预措施: 27T51 (Other)
Dose Expansion - Arm A
27T51 monotherapy
干预措施: 27T51 (Other)
Dose Expansion - Arm B
27T51+Cemiplimab
干预措施: 27T51 (Other)
Dose Expansion - Arm B
27T51+Cemiplimab
干预措施: Cemiplimab (Drug)
Dose Expansion - Arm C
27T51+Cemiplimab+Bevacizumab
干预措施: 27T51 (Other)
Dose Expansion - Arm C
27T51+Cemiplimab+Bevacizumab
干预措施: Cemiplimab (Drug)
Dose Expansion - Arm C
27T51+Cemiplimab+Bevacizumab
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events (TEAEs)
时间窗: Up to 18 months
Part 1a
Incidence of adverse events of special interest (AESIs)
时间窗: Up to 18 months
Part 1a
Incidence of adverse events of dose limiting toxicities (DLTs)
时间窗: Up to 18 months
Part 1a
Manufacturing feasibility of 27T51
时间窗: Up to 3 years
Phase 1a/1b Determination of the feasibility of manufacturing 27T51 is measured by the percent of leukapheresis products collected that are able to be manufactured and released for infusion.
Overall response rate (ORR) as assessed by the investigator
时间窗: Up to 48 months
Phase 1b
次要结局
- ORR as assessed by the investigator(Up to 48 months)
- Incidence of AESIs(Up to 48 months)
- Incidence of DLTs(Up to 48 months)
- Incidence of TEAEs(Up to 48 months)
- Duration of response (DoR)(Up to 48 months)
- Disease control rate (DCR)(Up to 48 months)