An Antibody-armored Dendritic Cell in Patients With Solid Tumors
Recruiting now · Phase 1
Conditions studied: Solid Cancers, Adjuvant Therapy
In brief
This study is a single-arm, open-label, single-administration dose-escalation study.
Key facts
- Study ID
- NCT07479667
- Run by
- Shanghai Cell Therapy Group Co.,Ltd
- People needed
- 8
- Starts
- 2026-02-05
- Expected to finish
- 2029-06-30
- Last updated by the study team
- 2026-03-18
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Shanghai Mengchao Tumor Hospital — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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