An Antibody-armored Dendritic Cell in Patients With Solid Tumors

Официальное название

An Exploratory, Single-arm, Open-label Study to Evaluate the Safety and Tolerability of Antibody-armored Dendritic Cell Injection Following a Single Administration in Patients With Solid Tumors

Обзор

This study is a single-arm, open-label, single-administration dose-escalation study.

Вмешательства

• Биопрепарат Armored Dendritic Cell Injection
  Armored dendritic cells are administered via multiple subcutaneous injections.

Первичные конечные точки

• Maximum Tolerated Dose [Срок оценки: Day 0-Month 5]
• Evaluate the incidence and severity of adverse events [Срок оценки: Day 0-Month 24]

Вторичные конечные точки (6)

• Cmax [Срок оценки: day 0-day28]
• antigen-specific T-cell responses [Срок оценки: day 0-Month 5]
• RFS [Срок оценки: day 0-Month 24]
• Tmax [Срок оценки: day 0- day 28]
• Tlast [Срок оценки: day 0-day 28]
• concentration of tumor markers [Срок оценки: day 0-month 5]

Критерии участия

Критерии включения

• Aged 18 to 80 years, body weight ≥ 40 kg; male or female, no gender restriction;
• ECOG performance status score of 0 to 1;
• Histopathologically confirmed solid tumors including pancreatic cancer, colorectal cancer (CRC), gastric cancer and other such malignancies;
• Having undergone R0 or R1 resection with completion of at least 4 cycles of standard postoperative adjuvant chemotherapy;
• Positive expression for at least one of TERT, P53, KRAS and Survivin;
• Sufficient venous access with no contraindications to peripheral blood mononuclear cell collection;
• Adequate organ and bone marrow function:
• a) Platelet count ≥ 90×10⁹/L;
• b) Hemoglobin ≥ 90 g/L (no blood transfusion or erythropoietin dependence within 7 days);
• c) Mononuclear cell count ≥ 1.0×10⁹/L;
• d) International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × upper limit of normal (ULN);
• e) Serum creatinine ≤ 1.5 × upper limit of normal (ULN);
• f) Aminotransferases (AST, ALT) ≤ 2.5 × upper limit of normal (ULN);
• g) Total bilirubin ≤ 2 × upper limit of normal (ULN);
• h) Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 50% as assessed by echocardiography within 1 month prior to enrollment;
• Able to understand the study requirements and considerations and provide informed consent to participate in the clinical study in accordance with the study requirements
• Subjects agree to use effective contraceptive measures for at least 6 months following dendritic cell (DC) injection.

Критерии исключения

• Women who are pregnant or breastfeeding;
• Positive for human immunodeficiency virus (HIV) antibody or syphilis antibody; positive for hepatitis B surface antigen (HBsAg), positive for hepatitis B core antibody (anti-HBc) or hepatitis B e antibody (anti-HBe) with hepatitis B virus (HBV) DNA copy number above the lower limit of detection (LLOD) or ≥ 1000 copies/mL; or hepatitis C virus (HCV) RNA copy number above the LLOD;
• Prior treatment with any dendritic cell (DC) or other immune cell therapy;
• History of hypersensitivity to immunotherapy and related drugs, or history of severe allergic reactions;
• Uncontrolled active infection;
• Subjects with active autoimmune disease receiving relevant treatment; subjects with organ transplantation who are still on immunosuppressive agents; or subjects requiring long-term use of immunosuppressive agents (> 15 mg/day prednisone or equivalent glucocorticoid dose) and who have used them within 4 weeks prior to screening;
• Presence of central nervous system (CNS) metastases and clinically significant CNS diseases;
• Received systemic anti-tumor therapy within 4 weeks prior to screening;
• Presence of residual lesions or unremoved foci on screening examinations (post-adjuvant chemotherapy / post-surgery), with imaging indicating local recurrence or confirmed distant metastasis;
• History of other active malignancies within 5 years (excluding cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, etc.);
• Clinically significant major cardiovascular diseases including:
• a) Symptomatic congestive heart failure
• b) Unstable angina pectoris
• c) Severe arrhythmia requiring pharmacotherapy
• d) Uncontrolled hypertension
• e) Myocardial infarction or ventricular arrhythmia within 6 months prior to screening;
• Any other conditions deemed by the investigator to render the subject ineligible for participation in the clinical study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Mengchao Tumor Hospital — Шанхай

Идентификаторы

NCT: NCT07479667 · JL104-A-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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