An Antibody-armored Dendritic Cell in Patients With Solid Tumors

Summary

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

Eligibility

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Conditions3

Interventions1

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