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Recruiting NCT07479667

An Antibody-armored Dendritic Cell in Patients With Solid Tumors

Phase I Interventional Solid Cancers Adjuvant Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Armored Dendritic Cell Injection.
Who it may be relevant to
Registry conditions: Solid Cancers, Adjuvant Therapy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Biological Armored Dendritic Cell Injection
    Armored dendritic cells are administered via multiple subcutaneous injections.

Primary outcome measures

  • Maximum Tolerated Dose [Time frame: Day 0-Month 5]
  • Evaluate the incidence and severity of adverse events [Time frame: Day 0-Month 24]
Secondary outcome measures (6)
  • Cmax [Time frame: day 0-day28]
  • antigen-specific T-cell responses [Time frame: day 0-Month 5]
  • RFS [Time frame: day 0-Month 24]
  • Tmax [Time frame: day 0- day 28]
  • Tlast [Time frame: day 0-day 28]
  • concentration of tumor markers [Time frame: day 0-month 5]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Mengchao Tumor Hospital — Shanghai

Identifiers

NCT: NCT07479667 · JL104-A-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗