NCT07479667 An Antibody-armored Dendritic Cell in Patients With Solid Tumors
| NCT ID | NCT07479667 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Cell Therapy Group Co.,Ltd |
| Condition | Solid Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2026-02-05 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 8 participants in total. It began in 2026-02-05 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a single-arm, open-label, single-administration dose-escalation study.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07479667 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Solid Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07479667 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07479667 currently recruiting?
Yes, NCT07479667 is actively recruiting participants. Contact the research team at xuqing@shcell.com for enrollment information.
Where is the NCT07479667 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07479667 clinical trial?
NCT07479667 is sponsored by Shanghai Cell Therapy Group Co.,Ltd. The trial plans to enroll 8 participants.
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