IRCT20230704058675N1招募中1 期
Evaluation of the safety and efficacy of allogeneic activated Natural killer cells in metastatic Colon Adenocarcinoma
Middle East Gene Therapy corporation0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 75 years（—）
- 性别
- All
入选标准
- •The expected survival period of the participants is at least 6 months
- •Patients with metastatic colon adenocarcinoma who have failed at least two standard lines of treatment and no other viable and effective treatment is available.
- •It should be possible to evaluate the metastatic lesion in the participants by radiological approaches. (CT and MRI)
- •The physical condition score of ECOG participants is 0-2.
- •Participants should have proper liver, kidney, and bone marrow function. Laboratory screening must meet the following criteria for all laboratory tests. WBC = 1.5 x 109/L. PLT platelet count =60×109/L. Hemoglobin Hb content of 8.0 g/dL or higher. Lymphocyte LYM=0.4×109/L. Serum creatinine =1.5 × ULN, if serum creatinine > 1.5 × ULN, creatinine clearance rate > 50 mL/min (calculated according to the Cockcroft-Gault formula). Total serum bilirubin =1.5×ULN, ALT=2×ULN, AST=2×ULN (patients with liver metastasis or liver cancer) ALT=5 x ULN, AST=5 x ULN). Amylase and lipase = 1.5 × ULN. Urine protein < 2+
- •Participants must be willing and able to comply with planned treatment regimens, laboratory tests, follow-up visits, and other study requirements.
- •Participants should be HIV negative and don't have active hepatitis B and C
排除标准
- •Patients with (MSI-H) phenotype will not be included in the study. (Patients with MSS molecular status will be included in the study).
- •Patients with metastasis in CNS or BM
- •Prior immunotherapy with NK or CAR-NK
- •received anti-PD-1/PD-L1 monoclonal antibody therapy within 4 weeks prior to treatment
- •Patients who have previously received other gene therapies
- •Patients who participated in other clinical studies in the last 1 month
- •Participants who have not received a maximum of 2 series of intermittent TB therapy out of 6 series of cell injections.
- •known history of human immunodeficiency virus (HIV) infection; acute or chronic active hepatitis B (HBsAg positive); Acute or chronic active hepatitis C (HCV antibody positive). Syphilis antibody positive; DNA quantity of Epstein-Barr virus 500 copies; Cytomegalovirus (CMV) infection (IgM positive).
- •Severe infection that is active or clinically poorly controlled.
- •Existing heart disease requiring treatment or hypertension not well controlled by the investigator (systolic blood pressure =140 mmHg and/or diastolic blood pressure >90 mmHg after treatment).
- •The presence of any clinical symptoms or heart diseases (ischemic heart disease, heart failure and arrhythmia)
- •Patients with chronic lung, heart and liver diseases.
- •Patients with active autoimmune disease; Rheumatoid arthritis, inflammatory bowel disease, celiac disease, systemic lupus erythematosus, scleroderma and multiple sclerosis.
- •Patients taking immunosuppressive drugs, including tacrolimus, mycophenolate mofetil, sirolimus, and cyclosporine A.
- •Patients with psychiatric diseases from whom it is not possible to obtain informed consent.
- •Abnormal coagulation function (INR > 1.5), bleeding tendency, or receiving thrombolytic or conventional anticoagulant therapy (eg, warfarin or heparin) in patients requiring long-term antiplatelet therapy (aspirin > 300 mg/day; clopidogrel, dose > 75 mg per day).
- •People requiring systemic treatment with corticosteroids or other immunosuppressive agents during the course of treatment.
- •Known past or present hepatic encephalopathy requiring treatment. Patients who currently have or have a history of central nervous system disorders such as epilepsy, seizures, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with central nervous system involvement.
- •Patients with previous or simultaneous malignancy
- •Participants who drop out of the study for various reasons and cannot participate in the study again
研究者
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