NCT02496273

Brief Summary

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 gastric-cancer

Timeline
56mo left

Started Jan 2016

Longer than P75 for phase_1 gastric-cancer

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jan 2016Dec 2030

First Submitted

Initial submission to the registry

July 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

February 22, 2016

Status Verified

February 1, 2016

Enrollment Period

10.9 years

First QC Date

July 9, 2015

Last Update Submit

February 19, 2016

Conditions

Gastric Cancer

Keywords

Dendritic CellsCytotoxic T-LymphocytesAdeno-Associated Virus

Outcome Measures

Primary Outcomes (1)

  • ELISPOT assays

    Enzyme-Linked ImmunoSpot (ELISPOT) assay is used for monitoring CEA specific cellular immune responses in Gastric Cancer

    1 month

Secondary Outcomes (1)

  • overall survival (OS)

    1 month

Study Arms (1)

CEA Specific CTL

EXPERIMENTAL

Patients receiving CEA-specific CTLs as therapy for Gastric Cancer

Biological: CTL

Interventions

CTLBIOLOGICAL

Mononuclear cells (Dendritic Cell,DC precursor) were isolated from the peripheral blood of gasric cancer by density gradient centrifugation and infected with rAAV/CEA virus.Maturation of the DC was induced by granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-4 (IL-4) and tumor necrosis factor-alpha(TNF-alpha). On day 7, the DCs were collected and mixed with T cells at the ratio of 1 to 20 to induce cytotoxic T lymphocytes (CTL).The cells will be proliferated and infused by intravenous (IV) infusion into the patient.

Also known as: CEA Specific Cytotoxic T-Lymphocytes
CEA Specific CTL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with severe active infection.
  • Patients receiving systemic corticosteroid within 48 hours of CTL infusion.
  • Patients with HBV,HCV,HIV infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Caruana 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: 25691731BACKGROUND

  • Cui 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: 23650543BACKGROUND

  • Martino 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: 23325831BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Wu Changping, M.D

    The First People's Hospital of Changzhou

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2015

First Posted

July 14, 2015

Study Start

January 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2030

Last Updated

February 22, 2016

Record last verified: 2016-02