Clinical trial · Interventional
Phase I Trial of CEA Specific AAV-DC-CTL Treatment in Stage IV Gastric Cancer
Phase 1 Study of CEA Specific Cytotoxic T Lymphocytes Induced by Dendritic Cells Infected by Recombinant Adeno-associated Virus With CEA Gene in Stage IV Gastric Cancer
NCT02496273CI-TRIAL-00021032active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the clinical safety and preliminary efficacy of CEA specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene in the treatment of stage IV gastric cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CTL | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CEA Specific CTL
- description
- Patients receiving CEA-specific CTLs as therapy for Gastric Cancer
- interventionNames
- Biological: CTL
Primary outcomes (1)
- measure
- ELISPOT assays
- timeFrame
- 1 month
- description
- Enzyme-Linked ImmunoSpot (ELISPOT) assay is used for monitoring CEA specific cellular immune responses in Gastric Cancer
Secondary outcomes (1)
- measure
- overall survival (OS)
- timeFrame
- 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient, at least 18 yrs old regardless of sex, with a diagnosis of Stage IV Gastric Cancer * Patients with life expectancy greater than or equal to 6 weeks. * Patients with a Karnofsky score of greater than or equal to 80. * serum CEA ≥ 20ng/ml. * Patient provides consent for all required biopsies. Exclusion Criteria: * Patients with severe active infection. * Patients receiving systemic corticosteroid within 48 hours of CTL infusion. * Patients with HBV,HCV,HIV infection.
References
Publications (3)
- BACKGROUNDCaruana I, Weber G, Ballard BC, Wood MS, Savoldo B, Dotti G. K562-Derived Whole-Cell Vaccine Enhances Antitumor Responses of CAR-Redirected Virus-Specific Cytotoxic T Lymphocytes In Vivo. Clin Cancer Res. 2015 Jul 1;21(13):2952-62. doi: 10.1158/1078-0432.CCR-14-2998. Epub 2015 Feb 17. PMID 25691731
- BACKGROUNDCui H, Zhang W, Hu W, Liu K, Wang T, Ma N, Liu X, Liu Y, Jiang Y. Recombinant mammaglobin A adenovirus-infected dendritic cells induce mammaglobin A-specific CD8+ cytotoxic T lymphocytes against breast cancer cells in vitro. PLoS One. 2013 May 1;8(5):e63055. doi: 10.1371/journal.pone.0063055. Print 2013. PMID 23650543
- BACKGROUNDMartino AT, Basner-Tschakarjan E, Markusic DM, Finn JD, Hinderer C, Zhou S, Ostrov DA, Srivastava A, Ertl HC, Terhorst C, High KA, Mingozzi F, Herzog RW. Engineered AAV vector minimizes in vivo targeting of transduced hepatocytes by capsid-specific CD8+ T cells. Blood. 2013 Mar 21;121(12):2224-33. doi: 10.1182/blood-2012-10-460733. Epub 2013 Jan 16. PMID 23325831