Actively Recruiting
An Antibody-armored Dendritic Cell in Patients With Solid Tumors
Led by Shanghai Cell Therapy Group Co.,Ltd · Updated on 2026-03-18
8
Participants Needed
1
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm, open-label, single-administration dose-escalation study.
CONDITIONS
Official Title
An Antibody-armored Dendritic Cell in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 80 years, body weight at least 40 kg; any gender
- ECOG performance status score of 0 to 1
- Histopathologically confirmed solid tumors including pancreatic, colorectal, gastric cancers, or similar malignancies
- Completed R0 or R1 tumor resection and at least 4 cycles of standard postoperative adjuvant chemotherapy
- Positive for at least one marker among TERT, P53, KRAS, and Survivin
- Suitable venous access with no contraindications for peripheral blood mononuclear cell collection
- Adequate organ and bone marrow function including platelet count ≥ 90×10⁹/L, hemoglobin ≥ 90 g/L without recent transfusion or erythropoietin use, mononuclear cell count ≥ 1.0×10⁹/L
- Normal coagulation with INR or PT ≤ 1.5 times upper limit of normal
- Kidney function with serum creatinine ≤ 1.5 times upper limit of normal
- Liver function with aminotransferases (AST, ALT) ≤ 2.5 times upper limit of normal and total bilirubin ≤ 2 times upper limit of normal
- Cardiac function with left ventricular ejection fraction ≥ 50% by echocardiography within 1 month prior to enrollment
- Able to understand study requirements and provide informed consent
- Agree to use effective contraception for at least 6 months following dendritic cell injection
You will not qualify if you...
- Pregnant or breastfeeding women
- Positive for HIV antibody or syphilis antibody
- Positive for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis B e antibody with HBV DNA above detection limit or ≥ 1000 copies/mL
- Positive for hepatitis C virus RNA above detection limit
- Prior treatment with dendritic cell or other immune cell therapy
- History of severe allergic reactions or hypersensitivity to immunotherapy or related drugs
- Uncontrolled active infections
- Active autoimmune disease under treatment
- Organ transplant recipients on immunosuppressive agents
- Use of long-term immunosuppressive drugs (>15 mg/day prednisone or equivalent) within 4 weeks prior to screening
- Presence of central nervous system metastases or significant CNS diseases
- Systemic anti-tumor therapy within 4 weeks prior to screening
- Residual tumor lesions, local recurrence, or confirmed distant metastasis after surgery or chemotherapy
- History of other active malignancies within 5 years except cured basal cell carcinoma or carcinoma in situ of the cervix
- Major cardiovascular diseases including symptomatic congestive heart failure, unstable angina, severe arrhythmia requiring treatment, uncontrolled hypertension, or recent myocardial infarction or ventricular arrhythmia within 6 months
- Any condition judged by investigators to make the subject ineligible for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Mengchao Tumor Hospital
Shanghai, China
Actively Recruiting
Research Team
X
Xu Qing
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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