NCT04812470已完成1 期
A Phase I Study Using Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma and Liver Metastases
Vastra Gotaland Region1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年2月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
The purpose of this study is to evaluate the feasibility, safety and tolerability of treatment with autologous tumor infiltrating lymphocytes (TIL) administered via hepatic arterial infusion in patients with liver metastases (including but not restricted to) of malignant melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18-75 years of age on the day of signing informed consent.
- •Patient is willing and able to provide written informed consent and comply with study procedures. Written informed consent must be signed and dated before the start of specific protocol procedures.
- •Patient must have a histologically/cytologically confirmed diagnosis of:
- •stage IV uveal melanoma with or without any previous systemic therapy OR
- •stage IV cutaneous melanoma with confirmed progression following at least one or two prior systemic therapies including a programmed cell death protein-1 (PD-1) inhibitor with or without a CTLA-4 inhibitor; and if BRAF V600 mutation-positive, also a BRAF inhibitor or a BRAF inhibitor in combination with a MEK inhibitor.
- •Measurable disease by computed tomography (CT) per RECIST 1.1 criteria with at least one target lesion identified in the liver and where the distribution pattern of metastasis is predominantly engaging the liver as judged by the investigator.
- •At least one resectable lesion in the liver (or aggregate of lesions resected) of a minimum size of 0.5 cm in diameter post- resection to generate TILs.
- •ECOG performance status of 0 -
- •Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •Female patients of childbearing potential must be willing to use a highly efficient method of contraception (Pearl index <1), for the course of the study through 120 days after the last dose of study medication.
- •Male patients with women of childbearing potential partners must agree to use a condom for contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
排除标准
- •Life expectancy of less than 3 months.
- •History of interstitial lung disease (ILD) or (non-infectious) pneumonitis.
- •Reduced renal function defined as S- Creatinine >=1.5xULN or Creatinine Clearance < 40 mL/min, calculated using the Cockroft and Gault formula.
- •Reduced hepatic function (defined as ASAT, ALAT, bilirubin > 3*ULN and PK- INR > 1.5) or medical history of liver cirrhosis or portal hypertension.
- •Hemoglobin <90 g/L or platelets <100x109/L or neutrophils <1.5x109/L
- •Use of live vaccines four weeks before or after the start of study.
- •History of severe hypersensitivity reactions to monoclonal antibodies.
- •Active infection.
- •Infection of human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C.
- •Active autoimmune disease or a history of known or suspected autoimmune disease.
- •A condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- •Concomitant therapy with any other anti- cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs.
- •Has a known additional malignancy of other diagnosis that is progressing or requires active treatment.
- •Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug.
- •A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
研究组 & 干预措施
Autologous tumor infiltrating lymphocytes (TIL)
Experimental
Autologous TIL administered via hepatic arterial infusion followed by low dose Interleukin-2 after preconditioning chemotherapy with Melphalan.
干预措施: Autologous Tumor Infiltrating Lymphocytes (Drug)
Autologous tumor infiltrating lymphocytes (TIL)
Experimental
Autologous TIL administered via hepatic arterial infusion followed by low dose Interleukin-2 after preconditioning chemotherapy with Melphalan.
干预措施: Melphalan (Drug)
Autologous tumor infiltrating lymphocytes (TIL)
Experimental
Autologous TIL administered via hepatic arterial infusion followed by low dose Interleukin-2 after preconditioning chemotherapy with Melphalan.
干预措施: Interleukin-2 (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
时间窗: 5 years from start of chemotherapy
Adverse events are graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
次要结局
- Progression free survival (PFS)(2 years)
- Duration of objective response (DOR)(2 years)
- hepatic Progression free survival (hPFS)(2 years)
- Objective response rate (ORR)(2 years from start of chemotherapy)
- Clinical benefit rate (CBR)(18 weeks)
- Evaluation of feasibility of an automated production of TILs(2 years)
- Overall Survival (OS)(5 years)
研究者
研究点 (1)
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