An Antibody-armored Dendritic Cell in Patients With Solid Tumors

NCT07479667 | Recruiting Phase 1

• 1 other identifier: JL104-A-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Cancers; Adjuvant Therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Cmax

  day 0-day28

• antigen-specific T-cell responses

  day 0-Month 5

• RFS

  day 0-Month 24

• Tmax

  day 0- day 28

• Tlast

  day 0-day 28

Study Arms (1)

Armored Dendritic Cell Injection

EXPERIMENTAL

Biological: Armored Dendritic Cell Injection

Interventions

Armored Dendritic Cell Injection BIOLOGICAL

Armored dendritic cells are administered via multiple subcutaneous injections.

Armored Dendritic Cell Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

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

Sponsors & Collaborators

• Shanghai Cell Therapy Group Co.,Ltd: lead

Study Sites (1)

Shanghai Mengchao Tumor Hospital

Shanghai, China

RECRUITING

Central Study Contacts

Xu Qing

CONTACT

13761325567; xuqing@shcell.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: March 18, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)