An Antibody-armored Dendritic Cell in Patients With Solid Tumors (dendritic cell)

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

Study Overview

• Status: Recruiting
• Conditions: Solid Cancers; Adjuvant Therapy
• Intervention / Treatment: Biological: Armored Dendritic Cell Injection

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xu Qing; Phone Number: 13761325567; Email: xuqing@shcell.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Mengchao Tumor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Armored Dendritic Cell Injection	Biological: Armored Dendritic Cell Injection; Armored dendritic cells are administered via multiple subcutaneous injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Tolerated Dose		Day 0-Month 5
Evaluate the incidence and severity of adverse events	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.	Day 0-Month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax		day 0-day28
antigen-specific T-cell responses		day 0-Month 5
RFS	1- and 2-year recurrence-free survival rates (RFS)	day 0-Month 24
Tmax		day 0- day 28
Tlast		day 0-day 28
concentration of tumor markers		day 0-month 5

Collaborators and Investigators

• Sponsor: Shanghai Cell Therapy Group Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: February 8, 2026
• First Submitted That Met QC Criteria: March 15, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: JL104-A-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No