Adjuvant Therapy, Solid Cancers
Conditions
Brief summary
This study is a single-arm, open-label, single-administration dose-escalation study.
Interventions
BIOLOGICALArmored Dendritic Cell Injection
Armored dendritic cells are administered via multiple subcutaneous injections.
Sponsors
Shanghai Cell Therapy Group Co.,Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose | Day 0-Month 5 | — |
| Evaluate the incidence and severity of adverse events | Day 0-Month 24 | Adverse events (AEs), serious adverse events (SAEs) and laboratory abnormalities (including their types, frequencies and severity) will be collected. This includes the types, incidence and severity of adverse events, as well as clinically significant abnormal laboratory test results and abnormal physical examination findings that emerge after treatment. Clinical and laboratory adverse events will be primarily graded using Version 6.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). The causal relationship between adverse events and the dendritic cell (DC) product will be assessed by investigators in accordance with the causality evaluation criteria specified in the study protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | day 0-day28 | — |
| antigen-specific T-cell responses | day 0-Month 5 | — |
| RFS | day 0-Month 24 | 1- and 2-year recurrence-free survival rates (RFS) |
| Tmax | day 0- day 28 | — |
| Tlast | day 0-day 28 | — |
| concentration of tumor markers | day 0-month 5 | — |
Countries
China
Contacts
CONTACTXu Qing
Outcome results
None listed