NCT05123209Unknown1 期
Safety and Efficacy Evaluation of IM83 CAR-T Cells for Patients Wirh Advanced Liver Tumors
Beijing Immunochina Medical Science & Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年8月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs) and abnormal laboratory test results as assessed by CTCAE V5.0
研究概览
简要总结
This is a open-label, single center, cohort study to determine the efficacy and safety of IM83 CAR-T cells in patients with advanced Liver Tumors.
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
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old, male or female.
- •Patients with advanced hepatocellular carcinoma (HCC) diagnosed by histopathology or cytology, Barcelona stage B-C.
- •Progression or intolerance after receiving standardized systematic treatment in the past (at least first-line treatment fails, and PD-1 / PD-L1 drugs can be used).
- •Patients in car-t combined treatment group need to have not received the combined drugs before.
- •At least one measurable target lesion according to RECIST1.
- •Tumor cells expressed GPC3 antigen.
- •Child Pugh score of liver function ≤
- •Estimated survival ≥ 12 weeks;
- •Laboratory inspection shall at least meet the following specified indicators:
- •ANC≥ 1.5 × 10 ^ 9 / L，platelet ≥ 75 × 10 ^ 9 / L ，Hemoglobin ≥ 90 g / L，Serum creatinine ≤ 1.5 ULN，serum bilirubin ≤ 3 ULN，INR≤ 2，AST and ALT)≤ 5.0 ULN，Creatinine clearance rate ≥ 60 ml / min.
- •The left ventricular ejection fraction was > 50%.
排除标准
- •The researcher has determined that the subject has autoimmune diseases that are not suitable to participate in this study, such as systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis.
- •History of epilepsy or other central nervous system diseases that may affect the test in the judgment of the investigator.
- •The washout period of chemotherapy, molecular targeted therapy, immunotherapy, hepatic artery chemoembolization, radiofrequency ablation, radiotherapy for non target lesions or other anti-tumor drugs within 1 week before blood collection is less than 5 half lives.
- •Systemic glucocorticoids (local use is allowed) or other immunosuppressants were used within 3 days before apheresis.
- •Other incurable malignant tumors in the past 5 years or at the same time, except cervical carcinoma in situ, skin basal cell carcinoma and breast ductal carcinoma in situ.
- •The investigator assessed that the subject had poorly controlled pleural effusion, ascites or pericardial effusion.
- •Hypertension with poor drug control (systolic blood pressure > 160mmhg and / or diastolic blood pressure > 90mmHg) or cardiovascular and cerebrovascular diseases with clinical significance (such as active) within 6 months before signing the informed consent, such as cerebrovascular accident, myocardial infarction, unstable angina pectoris, or severe arrhythmia, which cannot be controlled by drugs or has potential impact on the study treatment.
- •Combined with other serious organic diseases or mental diseases.
- •Subjects with HBsAg or HBcAbpositive and peripheral blood HBV DNA titers of >2000 IU/ml (HBsAg positive but HBV DNA titer <2000 IU/ml of peripheral blood and eligible for antiviral treatment according to chronic hepatitis B prevention guideline 2019 Edition). HCV antibody positive and HCV RNA in peripheral blood > 500 IU / ml. Syphilis antibody positive.
- •Male subjects who are pregnant or breastfeeding during the screening period, or who plan pregnancy during treatment or within 1 year after the end of treatment, or whose partner plans pregnancy within 1 year after the end of treatment.
- •There were active or uncontrollable infections requiring systemic treatment within 1 week before cell apheresis.
- •Other researchers believe that it is not suitable for inclusion.
结局指标
主要结局
Incidence of adverse events (AEs) and abnormal laboratory test results as assessed by CTCAE V5.0
时间窗: Up to 28 days after CAR-T cell infusion
次要结局
- Duration of Response (DOR)(Up to 24 weeks after CAR-T cell infusion)
- Objective response rate (ORR)(At 28 days, 3 months and 6 months after CAR-T cell infusion)
- Progression-free survival (PFS)(Up to 24 weeks after CAR-T cell infusion)
- Plasma levels of α fetoprotein (AFP) cells infusion(At 28 days, 3 months and 6 months after CAR-T cell infusion)
- Overall survival (OS)(Up to 24 weeks after CAR-T cell infusion)
- Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood)(Up to 24 weeks after CAR-T cell infusion)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
Evaluate the Safety and Efficacy of CD33 CAR-T in Patients With R/R AMLAMLNCT05473221Zhejiang University20
Unknown
1 期
Novel GPC3 CAR-T Cell Therapy for Hepatocellular CarcinomaNCT05344664Peking University12
终止
1 期
Study Evaluating Safety and Efficacy of CAR-T Cells Targeting CD123 in Patients With Acute LeukemiaAcute Leukemia in RelapseRelapsed or Refractory Acute LeukemiaAcute Myeloid LeukemiaAcute LeukemiaNCT03672851Second Affiliated Hospital of Xi'an Jiaotong University2
已完成
1 期
CD19 /22 CAR T Cells (AUTO3) for the Treatment of B Cell Acute Lymphoblastic Leukemia (ALL)B Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Lymphoblastic LeukemiaRefractory Childhood Acute Lymphoblastic LeukemiaB-cell Acute Lymphoblastic LeukemiaNCT03289455Autolus Limited23
终止
1 期
Cluster of Differentiation Antigen 19/22(CD19/22) CAR T Cells (AUTO3) for the Treatment of Diffuse Large B Cell LymphomaNCT03287817Autolus Limited52