A Phase 1/2 Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Preliminary Eficacy of Autologous SCG142 T Cell Receptor (TCR) T Cells in Patients With Advanced or Metastatic HPV16- or HPV52-positive Carcinomas
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (Phase 1)
研究概览
简要总结
This is a phase 1/2, open-label, single arm, multicenter study in patients with advanced or metastatic HPV16- or HPV52-positive carcinomas who have progressed after at least one line of systemic therapy, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy
详细描述
This study will be conducted in 2 parts:
The Phase 1 part of the trial consists of a dose-escalation portion designed to evaluate the safety and tolerability of SCG142, and to identify the RP2D.
The Phase 2 part of the trial is designed to evaluate the preliminary efficacy of SCG142 in the same patient populations.
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
- •Histologically confirmed squamous cell carcinoma (SCC); may include any of the following tumor types: cervical, head and neck, anal, penile, vulvar, or vaginal.
- •Tumor tissue positive for HPV16 or HPV
- •Advanced or metastatic carcinoma with progression after at least 1 line of standard of care systemic therapies, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy.
- •Human leukocyte antigen (HLA)-A*02:01 genotype.
- •Measurable disease as defined by RECIST v1.
- •Eastern Cooperative Group (ECOG) Performance Status of 0 or
- •Anticipated life expectancy ≥3 months.
- •Adequate laboratory parameters including hematologic, renal, hepatic and coagulation function.
排除标准
- •Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement.
- •Active brain metastasis or leptomeningeal metastases.
- •History of other malignancy within 2 years prior to Screening.
- •History of organ transplant.
- •Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- •History of active cardiac disease.
- •History of active pulmonary disease.
- •Active, known, or suspected autoimmune disease.
- •Lack of peripheral venous or central venous access, or any condition that may prevent trial sample collection and administration of SCG
- •Prior exposure to any cell therapy including, but not limited to natural killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DCs), cytotoxic T lymphocytes (CTLs), stem cell therapy, and CAR/TCR-T cell therapy.
- •Allergy to LD chemotherapy (cyclophosphamide or fludarabine) and/or any component of SCG
- •Any serious medical condition or abnormality in clinical laboratory tests.
研究组 & 干预措施
SCG142 T cells
This is a single arm study.
干预措施: SCG142 (Biological)
SCG142 T cells
This is a single arm study.
干预措施: Cyclophosphamide (Drug)
SCG142 T cells
This is a single arm study.
干预措施: Fludarabine (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (Phase 1)
时间窗: 2 years
Incidence of dose-limiting toxicities (DLTs) and occurrence of study related adverse events.
Objective response rate (ORR) (Phase 2)
时间窗: 2 years
The proportion of patients with a complete response (CR) or partial response (PR)
次要结局
- Objective response rate (ORR) (Phase 1)(2 year)
- Duration of objective response (DOR) (Phase 1&2)(2 year)
- Disease control rate (DCR) (Phase 1&2)(2 year)
- Progression-free survival (PFS) (Phase 1&2)(2 year)
- Overall survival (OS) (Phase 1&2)(2 year)
- Incidence of Treatment-Emergent Adverse Events (Phase 2)(2 years)