Actively Recruiting
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
Led by Shanghai Cell Therapy Group Co.,Ltd · Updated on 2026-03-18
8
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a single-arm, open-label study to evaluate the safety and tolerability of an antibody-armored dendritic cell injection in patients with solid tumors. This phase 1 trial focuses on patients with various types of solid cancers who have undergone surgery and standard chemotherapy. The study aims to determine the maximum tolerated dose and monitor adverse events over an extended period. Participants will receive a single administration of armored dendritic cells through multiple subcutaneous injections. The study is non-randomized and open-label, meaning all participants receive the same investigational treatment without placebo comparison. The dosing and safety will be assessed from day 0 up to 5 months, with additional monitoring of immune responses and tumor markers. Throughout the study, participants will be closely monitored with evaluations including laboratory tests, immune response assessments, and safety observations up to 24 months. Researchers will measure the concentration of tumor markers, T-cell responses, and adverse events to evaluate the treatment's impact and safety profile. Participants must meet specific health and organ function criteria and will be followed for up to two years to track outcomes and side effects.
CONDITIONS
Brief 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; male or female
- ECOG performance status score of 0 to 1
- Histopathologically confirmed solid tumors such as pancreatic, colorectal, or gastric cancer
- Completed R0 or R1 tumor resection and at least 4 cycles of standard postoperative adjuvant chemotherapy
- Positive expression for at least one of TERT, P53, KRAS, or Survivin
- Sufficient venous access for peripheral blood mononuclear cell collection
- Adequate organ and bone marrow function including platelets, hemoglobin, mononuclear cells, INR/PT, creatinine, liver enzymes, bilirubin, and cardiac function (LVEF ≥ 50%)
- Ability to understand and consent to study participation
- Agreement to use effective contraception for at least 6 months after dendritic cell injection
You will not qualify if you...
- Pregnant or breastfeeding women
- Positive for HIV, syphilis, hepatitis B or C infection above specified thresholds
- Prior treatment with dendritic cell or other immune cell therapy
- History of severe allergic reactions or hypersensitivity to immunotherapy
- Uncontrolled active infection
- Active autoimmune disease under treatment, organ transplant recipients on immunosuppressants, or recent use of immunosuppressive agents
- Central nervous system metastases or significant CNS diseases
- Systemic anti-tumor therapy within 4 weeks before screening
- Residual tumor lesions or confirmed local recurrence/distant metastasis
- Other active malignancies within 5 years except certain cured cancers
- Significant cardiovascular diseases including symptomatic heart failure, unstable angina, severe arrhythmia, uncontrolled hypertension, recent myocardial infarction or ventricular arrhythmia
- Any other condition making participation unsuitable as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0
Participants receive a single administration of antibody-armored dendritic cell injections via multiple subcutaneous injections.
1 treatment visit (in-person)
Duration - Up to 24 months
Participants are monitored for safety and tolerability including adverse events and immune response evaluations after the injection.
Regular visits for safety and response monitoring up to 24 months
Trial Site Locations
Total: 1 location
1
Shanghai Mengchao Tumor Hospital
Shanghai, China
Actively Recruiting
Research Team
X
Xu Qing
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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