Antibody-armored dendritic cell therapy for people with solid tumors

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

This will test a single injection of antibody-armored dendritic cells in adults with certain resected solid tumors after standard adjuvant chemotherapy to see if it is safe and stimulates an immune response.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Cell Therapy Group Co.,Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 1 site (Shanghai)
• Trial ID: NCT07479667 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, single-arm, open-label, single-administration dose-escalation trial of an antibody-armored dendritic cell product in adults with histologically confirmed solid tumors who have completed at least four cycles of postoperative adjuvant chemotherapy. Eligible participants must have undergone R0 or R1 resection and show positive expression for at least one of TERT, P53, KRAS or Survivin, with ECOG 0–1 and adequate organ and bone marrow function. The intervention involves collecting peripheral blood mononuclear cells, manufacturing the armored dendritic cells, and delivering a single injection while closely monitoring for safety and dose-limiting toxicities. Secondary observations will likely include immune response measures and preliminary signals of recurrence prevention.

Who should consider this trial

Good fit: Ideal candidates are adults 18–80 years old with resected solid tumors (for example pancreatic, colorectal, gastric) who completed at least four cycles of adjuvant chemotherapy, have tumors positive for TERT, P53, KRAS or Survivin, ECOG 0–1, and adequate blood and organ function.

Not a fit: Patients with unresected or widely metastatic disease, poor performance status (ECOG >1), inadequate organ or marrow function, inability to provide sufficient mononuclear cells, or tumors lacking the required marker expression are unlikely to benefit.

Why it matters

Potential benefit: If successful, the therapy could boost anti-tumor immunity after surgery and potentially lower the risk of cancer recurrence.

How similar studies have performed: Previous dendritic cell vaccine approaches have produced immune responses but limited definitive survival benefit in solid tumors, and antibody-armored dendritic cells are a relatively novel approach with limited clinical data to date.

Eligibility criteria

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

Where this trial is running

Shanghai

• Shanghai Mengchao Tumor Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Xu Qing

Conditions Solid Cancers; Adjuvant Therapy