NCT06370026尚未招募早期 1 期
KSD-101 Therapy for Standard Treatment Failed EBV-associated Nasopharyngeal Carcinoma: an Exploratory Clinical Trial
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年5月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The incidence Adverse events (Safety endpoint)
研究概览
简要总结
The main purpse of this study is to evaluate the safety of KSD-101 in patients with EBV-associated Nasopharyngeal Carcinoma,to evaluate the initial clinical outcomes and evaluate the immune response to KSD-101 for the treatment in Patients with EBV-associated Nasopharyngeal Carcinoma.
详细描述
This is a single-center, single-arm, open, multiple-dose clinical study evaluating the safety, preliminary efficacy, and immune response of KSD-101 for the treatment of patients with EBV-associated nasopharyngeal carcinoma.
Approximately 120 mL of PBMCs is collected from subjects. The collected PBMCs are transported to the manufacturing facility for the preparation of KSD-101. Subjects return to the study site for subsequent visits at investigator-notified times.
- KSD-101 route of administration: subcutaneous injection.
- KSD-101 treatment dose: 5.0 × 10^6 cells/dose.
- KSD-101 treatment frequency: once every 2 weeks for a total of 3-5 times. The 4th and 5th times are booster treatments, which need to be decided by the investigator according to the condition of the subjects.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients or their legal guardian voluntarily participate and sign an informed consent form.
- •Female or emale patients aged 18-70 years (inclusive of the cut-off value) on the date of signing the informed consent.
- •Nasopharyngeal carcinoma confirmed by pathological tissue examination and EBER-positive in tumor tissue by in situ hybridization (ISH or FISH).
- •Nasopharyngeal carcinoma that has failed 3rd or more line treatment and has localized recurrence or localized recurrence with systemic metastasis or primary metastatic nasopharyngeal carcinoma that is not suitable for localized or radical treatment.
- •At least one measurable lesion according to RECIST v1.1 criteria.
- •An Eastern Cooperative Oncology Group (ECOG) score of 0 to
- •Have criteria for single or venous blood collection and have no other contraindications to cell collection.
- •Patients' laboratory findings are compatible:
- •Blood routine: neutrophils ≥ 1.5×10^9/L, hemoglobin ≥ 90g/L, platelets ≥ 100×10^9/L.
- •Liver function: ALT, AST ≤ 3 × ULN and total bilirubin ≤ 1.5 × ULN.
- •Renal function: creatinine ≤ 1.5 × ULN.
- •Cardiac function: left ventricular ejection fraction (LVEF) ≥ 40%.
- •Coagulation function: fibrinogen ≥ 1.0g/L, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN.
- •Patients' corresponding lymph node region can accommodate subcutaneous injections.
- •Expected survival ≥ 3 months.
排除标准
- •Patients receiving any anti-tumor therapy such as chemotherapy, radiotherapy, immunosuppressive therapy, etc. within 4 weeks prior to mono-collection.
- •Women who are pregnant (positive urine/blood pregnancy test), breastfeeding, or men or women who are planning to conceive within the last 1 year.
- •Active hepatitis B (HbsAg or HbcAb positive and HBV DNA ≥100 IU/mL), active hepatitis C (HCV antibody positive and peripheral blood HCV RNA positive); human immunodeficiency virus (HIV) antibody positive; syphilis test positive.
- •Patients with central nervous system pathology (e.g., cerebral edema, need for hormonal intervention, or progression of brain metastases).
- •Patients with uncontrollable infectious disease within 4 weeks prior to enrollment, or with active tuberculosis or on anti-tuberculosis therapy. (< CTCAE grade 2 genitourinary infections and upper respiratory tract infections, except EBV infections).
- •Patients have a serious underlying disease (cardiovascular disease, respiratory disease, renal insufficiency, coagulation abnormality, autoimmune disease or immunodeficiency disease, etc.).
- •Other active malignant tumors within the past 3 years, unless they are curable tumors and have been significantly cured, such as basal or squamous cell carcinoma, carcinoma in situ of the uterine cervix or breast.
- •Subjects who have undergone major surgery or severe trauma within 4 weeks prior to enrollment or are expected to require major surgical intervention (i.e., surgery requiring the assistance of endotracheal anesthesia) during the study period.
- •Patients have received a prophylactic live or live attenuated vaccine within 4 weeks prior to screening.
- •Patients have participated in another clinical study within 4 weeks prior to screening.
- •Patients with a prior history of severe drug allergy, or penicillin allergy.
- •Patients have substance abuse/addiction.
- •Patients have other conditions that, in the judgment of the investigator, make enrollment inappropriate.
结局指标
主要结局
The incidence Adverse events (Safety endpoint)
时间窗: 1 year after DC Vaccines injection
Adverse events will be graded according to the NCI-CTCAE 5.0 grading criteria throughout the study period, except for injection site (localized) adverse events, which will be graded with reference to the Guidelines for Grading Criteria for Adverse Events in Clinical Trials of Vaccines for Prophylaxis.
次要结局
- According to EQ-5D-5L(Up to 1 year)
- Progression-free survival (PFS)(1 year after DC Vaccines injection)
- Levels of EBV-specific CD8+ T cells(1 year after DC Vaccines injection)
- According to EORTC QLQ-C30(Up to 1 year)
- According to EORTC QLQ-H&N35(Up to 1 year)
- EBV-DNA load(1 year after DC Vaccines injection)
- Objective response rate (ORR)(1 year after DC Vaccines injection)
- Disease control rate (DCR)(1 year after DC Vaccines injection)
- Overall survival (OS)(1 year after DC Vaccines injection)
- Levels of NK cells(1 year after DC Vaccines injection)
- Duration of response (DOR)(1 year after DC Vaccines injection)
- Levels of B cells(1 year after DC Vaccines injection)
- According to ECOG fitness status(Up to 1 year)
研究者
Fei Han
Professor
Sun Yat-sen University
研究点 (1)
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