Safety and Efficacy Study for MG-7-DC Vaccine in Gastric Cancer Treatment
NCT ID: NCT04567069
Last Updated: 2020-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2020-09-30
2022-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CKD-702 Plus Irinotecan in Gastric Cancer
NCT05750290
First-Line and Neoadjuvant Immunotherapy for Gastric Cancer
NCT06727981
Study of S-1 Plus DC-CIK for Patients With Advanced Gastric Cancer
NCT01783951
Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Metastatic Gastric Cancer
NCT01305993
Study of DP303c Injection in Patients With Advanced or Metastatic Gastric Cancer
NCT04826107
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
DC and CTL are immune cells. PD-1 monoclonal antibody is an immune checkpoint inhibitor. According to the relevant experience of similar cells or drugs, some patients may have delayed or early pseudo-tumor progression after receiving immunotherapy, which needs to be judged by investigators.
In this study, the screening period is no more than 14 days. After the screening examination and evaluation, the eligible patients will enter the treatment period. The treatment and follow-up are carried out according to the procedure. The follow-up period: tumor imaging evaluation and related clinical indicator evaluation are carried out at the 4th week (± 1 week), the 12th week (± 1 week), the 24th week (± 1 week), the 36th week (± 1 week) and the 48th week (± 1 week) after the treatment. The patients should also complete the corresponding safety inspection and evaluation before leaving the group. During the follow-up period, the patients who do not have disease progression but do leave the group should continue to be evaluated according to the original frequency until the end of the follow-up period or the start of other anti-tumor treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DC vaccine
Vaccine made from autologous dendritic cells loaded with MG-7 antigen.
DC vaccine
Blood samples will be collected twice, 60-120ml/ time. The 1st collection will occur 5 days before the 1st DC vaccine injection, the 2nd collection will occur 15 days after the 1st injection.
Six subcutaneous(ih) injections of DC vaccine will be given at days 1, 8, 15, 21, 28, 35; 1-3×106 cells/time.
Injection site: inguinal lymph nodes.
DC vaccine + CTL (cytotoxic lymphocyte)
Cytotoxic lymphocytes are CD3+ T cells co-cultured with DCs.
DC vaccine
Blood samples will be collected twice, 60-120ml/ time. The 1st collection will occur 5 days before the 1st DC vaccine injection, the 2nd collection will occur 15 days after the 1st injection.
Six subcutaneous(ih) injections of DC vaccine will be given at days 1, 8, 15, 21, 28, 35; 1-3×106 cells/time.
Injection site: inguinal lymph nodes.
CTL
Four intravenous (iv) drip injections of CTL will be given at days 7, 9, 27, 29; 1-2×109 cells/time.
DC vaccine + PD-1 monoclonal antibody (Sintilimab Injection)
Sintilimab injection is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells.
DC vaccine
Blood samples will be collected twice, 60-120ml/ time. The 1st collection will occur 5 days before the 1st DC vaccine injection, the 2nd collection will occur 15 days after the 1st injection.
Six subcutaneous(ih) injections of DC vaccine will be given at days 1, 8, 15, 21, 28, 35; 1-3×106 cells/time.
Injection site: inguinal lymph nodes.
Sintilimab Injection
The Sintilimab Injection (3mg/kg) will be administered by intravenous (iv) drip injection at days 0, 20。
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DC vaccine
Blood samples will be collected twice, 60-120ml/ time. The 1st collection will occur 5 days before the 1st DC vaccine injection, the 2nd collection will occur 15 days after the 1st injection.
Six subcutaneous(ih) injections of DC vaccine will be given at days 1, 8, 15, 21, 28, 35; 1-3×106 cells/time.
Injection site: inguinal lymph nodes.
CTL
Four intravenous (iv) drip injections of CTL will be given at days 7, 9, 27, 29; 1-2×109 cells/time.
Sintilimab Injection
The Sintilimab Injection (3mg/kg) will be administered by intravenous (iv) drip injection at days 0, 20。
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients should be within age range of ≥18 and ≤80 years old, competent, have signed informed consent and have a life expectancy greater than 6 months.
3. Failed in previous standard therapy ( surgery, chemotherapy, radiotherapy, and targeted therapy) or recurred from previous therapy, patients must be at least 1 month from their last therapy.
4. Patients without indications of surgery, radiotherapy or chemotherapy.
5. Patients who can't tolerate radiotherapy or chemotherapy.
6. Patients who refuse radiotherapy or chemotherapy.
7. Have measurable lesion by RECIST 1.1 criteria.
8. Karnofsky Performance Status (KPS) ≥60.
9. Patients must be willing to enroll the clinical study, and comply with the study and follow-up procedures.
10. Adequate organ and bone marrow functions:
1. White Blood Count (WBC) ≥ 3,000/mm3 (3.0×109/L);
2. Neutrophils≥ 1,000/mm3 (1.0×109/L);
3. Platelets (PLT) ≥ 80,000/mm3 (80×109/L);
4. Hemoglobin（Hb）≥ 9 g/dL (90g/L);
5. Serum creatinine ≤ 1.5x the upper limit of normal (ULN) or creatinine clearance (CrCl)≥ 40 mL/min;
6. Bilirubin≤ 1.5x ULN;
7. Aspartate Aminotransferase (AST) ≤ 2.5x ULN or Alanine Aminotransferase (ALT) ≤ 2.5x ULN; patients with liver metastasis must be ≤5x ULN;
8. International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;
9. Urine protein \< 2 +; if urinary protein ≥ 2 +, the 24-hour urine protein quantification must be ≤ 1g.
Exclusion Criteria
2. Patients who received systemic anti-tumor therapy and local treatment (radiotherapy, ablation and embolization) for gastric cancer within 1 month.
3. Patients who have active autoimmune diseases and need systemic immunosuppressive therapy.
4. Life expectancy \< 6 months.
5. Patients with organ allografts.
6. Women who are pregnant or nursing/breastfeeding
7. Allergic to allogeneic protein.
8. Human immunodeficiency virus (HIV) infection, untreated active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU / ml; hepatitis C, defined as HCV-RNA higher than the detection limit of the analytical method).
9. For any other reasons, the patients are believed not suitable for participation in this study by investigators .
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shandong Sunstem Biotechnology Co.,Ltd.
UNKNOWN
The Second Hospital of Shandong University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The 2nd Hospital of Shandong University
Jinan, Shandong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DC-S-Ⅰ/Ⅱ
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.