肿瘤细胞治疗研究
英文原题：DC/NK Cell Therapy
DC/NK Cell Therapy
这是一项 II 期注册临床试验，评估自体NK 细胞治疗肺癌的安全性、可行性及初步疗效。当前状态：招募中。计划入组 10 例。试验地点：中国 · 虎尾（共 1 个中心，其中中国 1 个）。登记号：NCT07202611。
不限性别 · ≥ 20 Years
纳入标准： 1. 受试者资格：组织学或细胞学诊断为IIIB或IV期非小细胞肺癌（NSCLC），或经多模式治疗（放疗、手术切除或局部晚期疾病的根治性放化疗）后复发/进展；晚期NSCLC至少接受过2种全身治疗，包括含铂化疗、抗PD-1治疗和/或其他靶向治疗； 2. 至少有一个可测量病灶；细胞治疗期间不得对该病灶进行放疗； 3. 年龄≥20岁； 4. 体重40–100 kg； 5. 细胞制备采血前4周内检查血常规正常：白细胞≥3000/mm³；淋巴细胞≥1000/mm³；血红蛋白≥10 g/dL；血小板≥100,000/mm³； 6. 细胞制备采血前4周内肝肾功能正常：肌酐≤1.25×ULN；总胆红素≤1.5×ULN；SGOT（AST）≤3×ULN；SGPT（ALT）≤3×ULN； 7. 已签署知情同意书； 8. ECOG体能状态评分0–1分； 9. 有生育能力的女性同意试验期间使用有效避孕措施。 排除标准： 1. 以下感染检测阳性：HCV抗体阳性、HBsAg阳性、HIV抗体阳性、HTLV抗体阳性、梅毒螺旋体抗体阳性或结核培养阳性； 2. ECOG体能状态评分2–4分； 3. 不能耐受白蛋白； 4. 医生估计预期生存期<12周； 5. 入组前30天内参加其他临床试验； 6. 妊娠检测阳性或正在哺乳； 7. 其他疾病，包括免疫缺陷、严重心肺功能障碍、凝血障碍、既往癌症治疗副作用尚未恢复至CTCAE 1级、既往移植手术，或医生认为不适合者； 8. 无法遵守随访或检查程序； 9. 过去2年内诊断其他癌症； 10. 特定并发症：脑转移、软脑膜疾病或脊髓压迫。
Inclusion Criteria:
1. Eligibility of Participants:
o Diagnosed histologically or cytologically with stage IIIB or stage IV non-small cell lung cancer (NSCLC) or patients with recurrence or progression following multimodal treatments (radiotherapy, surgical resection, or therapeutic chemoradiotherapy for locally advanced disease).
* Have undergone at least two systemic therapies for advanced NSCLC, including platinum-based chemotherapy, anti-PD-1 therapy, and/or other targeted therapies.
2. At Least One Measurable Lesion:
o The measurable lesion must not undergo radiotherapy during the cell therapy period.
3. Age:
o ≥20 years.
4. Weight:
o Between 40 and 100 kg.
5. Normal Blood Count (based on test results within 4 weeks before blood collection for cell preparation):
o White blood cells (WBC): ≥3000/mm³.
o Lymphocytes: ≥1000/mm³.
* Hemoglobin: ≥10 g/dL.
* Platelets: ≥100,000/mm³.
6. Normal Liver and Kidney Function (based on test results within 4 weeks before blood collection for cell preparation):
* Creatinine: ≤1.25× the upper limit of normal (ULN).
* Total bilirubin: ≤1.5× ULN.
* SGOT (AST): ≤3× ULN.
* SGPT (ALT): ≤3× ULN.
7. Informed Consent:
o Participants must sign the consent form.
8. ECOG Performance Status:
o Score of 0-1.
9. For Women of Childbearing Age:
* Must agree to use effective contraception during the trial.
Exclusion Criteria:
1. Positive Test Results for the Following Infections:
o HCV (HCV antibody-positive).
* HBV (HBsAg-positive).
* HIV (HIV antibody-positive).
* HTLV (HTLV antibody-positive).
* Syphilis (Treponema pallidum antibody-positive).
* Tuberculosis (TB culture-positive).
2. ECOG Performance Status:
o Score of 2-4.
3. Albumin Intolerance:
o Participants who cannot tolerate albumin.
4. Short Life Expectancy:
o Life expectancy estimated by the physician to be less than 12 weeks.
5. Participation in Other Clinical Trials:
o Within 30 days prior to entering this trial.
6. Pregnancy or Breastfeeding:
o Positive pregnancy test or currently breastfeeding.
7. Other Medical Conditions:
o Immunodeficiency, severe heart or lung dysfunction, coagulation disorders, unresolved side effects from prior cancer therapy (not recovered to CTCAE grade 1), prior transplant surgery, or deemed unsuitable by the physician.
8. Noncompliance:
o Unable to adhere to follow-up or examination procedures.
9. Concurrent Cancer:
o Other cancers diagnosed within the past 2 years.
10. Specific Complications:
* Brain metastases, leptomeningeal disease, or spinal cord compression.以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：Incidence and Severity of Adverse Events Following Administration of Autologous Dendritic Cells (via Axillary Lymph Node Injection) and Natural Killer Cells (via Intravenous Injection) cultured in vitro · The primary objective of this trial is to evaluate the safety profile of in vitro-cultured dendritic cells (DCs) and natural killer (NK) cells. Specifically, the study will assess adverse reactions, including incidence, type, and severity of treatment-emergent adverse events, following administration of autologous DCs via axillary lymph node injection and NK cells via intravenous injection. · 12 weeks
次要终点：Number of Participants with Successful Cultured Cell Preparation (Defined by ≥80% Cell Viability and Absence of Contamination)；Validation of Antitumor Effectiveness (In Vitro)；Proportion of Participants with Tumor Response (Complete Response, Partial Response, or Stable Disease per RECIST v1.1)
主要结局：本试验主要目标是检验体外培养的树突状细胞（DC）和自然杀伤细胞（NK）制剂的安全性。通过评估腋窝淋巴结注射自体DC及静脉注射NK细胞后的反应，确定这些试验产品用于人体的安全性特征。 次要结局：验证培养细胞制剂的成功率，并评估NK细胞靶向杀伤肿瘤细胞的细胞毒能力。次要目标包括：1.验证细胞制备成功：评估培养的自体DC和NK细胞的增殖率、回收率、存活率及肿瘤杀伤能力；2.验证抗肿瘤效果：评估腋窝淋巴结注射自体DC和静脉输注自体NK细胞的抗肿瘤疗效。
Primary Outcomes The primary objective of this trial is to test the safety of formulations containing dendritic cells (DCs) and natural killer (NK) cells cultured in vitro. By evaluating the reactions following the administration of autologous dendritic cells via axillary lymph node injection and natural killer cells via intravenous injection, the study aims to determine the safety profile of these trial products for human use. Secondary Outcomes To verify the success rate of the cultured cell formulations and assess the cytotoxic capacity of natural killer cells in targeting and killing tumor cells. The evaluation of these secondary objectives involves analyzing specific subcategories, which can be divided into two major components: 1. Validation of Cultured Cell Preparation Success: Assessing the proliferation rate, recovery rate, survival rate, and tumor-killing capacity of the cultured autologous dendritic cells and natural killer cells. 2. Validation of Antitumor Effectiveness: Evaluating the antitumor efficacy of the trial products administered via axillary lymph node injection of autologous dendritic cells and intravenous infusion of autologous natural killer cells.
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