NCT05117138Unknown1 期
Safety and Efficacy of Chimeric Antigen Receptor T Lymphocytes for Patients With Intermediate and Advanced Tumors
Beijing Immunochina Medical Science & Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2022年1月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This was a single arm, open-label, single center, cohort study to determine the efficacy and safety of AMT-116 CAR-T cells in patients with moderate or far advanced non-small cell lung carcinoma (NSCLC) and squamous cell cancer of the head and neck (HNSCC)，AMT-253 CAR-T cells in patients with moderate or far advanced melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old, both men and women, and the survival period is more than 6 months.
- •At least one assessable focus, failure of previous multi-line treatment or stable condition after treatment.
- •Patients with melanoma confirmed by histopathology, patients with non-small cell lung cancer(squamous carcinoma) and head and neck squamous cell carcinoma.
- •The surgically removed pathological tissue can be used for immunohistochemical detection of target protein (paraffin section should be within 5 years), and the positive expression of target protein in line with pathological diagnosis (immunohistochemical staining + + or + + +).
- •Sufficient venous access for blood sampling and venous blood sampling, no contraindications for lymphocyte collection.
- •Routine blood examination: white blood cell count (WBC) ≥ 3 × 10^9 / L, lymphocyte count (ly) ≥ 0.8 × 10^9 / L, hemoglobin (HB) ≥ 90g / L, platelet (PLT) ≥ 80 × 10^9/L.
- •Liver and kidney function: alanine aminotransferase and aspartate aminotransferase < 3 ULN, total bilirubin (TBIL) < 1.5 ULN, serum creatinine (SCR) < 2 ULN.
- •The subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
排除标准
- •Active hepatitis B or hepatitis C virus, HIV infection, or other unhealed active infections.
- •Patients with second tumor.
- •Patients previously treated with car-t cells.
- •Requiring long-term use of immunosuppressants for any reason.
- •Any serious and uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease and temporal arteritis.
- •Subjects with severe heart, lung, liver and kidney dysfunction or severe lung diseases.
- •Current systemic use of steroid cells (except for recent or current use of inhaled steroids).
- •Pregnant and lactating subjects.
- •Allergic to immunotherapy and related cells.
- •Subjects with a history of organ transplantation or waiting for organ transplantation.
- •After evaluation, the investigator considered that the subjects were unable or unwilling to comply with the requirements of the study protocol.
结局指标
主要结局
Incidence of adverse events
时间窗: 24 weeks
Overall Response Rate (ORR)
时间窗: 24 weeks
One year recurrence rate
时间窗: 24 weeks
次要结局
- Progression-Free Survival(PFS)(24 weeks)
- Relapse Free Survival(RFS)(24 weeks)
研究者
研究点 (1)
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