search
Back to results

Genetically Modified Mesenchymal Stem Cell Theraopeutic Against Head and Neck Cancer (GX-051)

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GX-051
Sponsored by
Genexine, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring head and neck cancer, gene therapy, stem cell therapy, immunotherappy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Are capable of understanding and complying with the requirements of the study and have signed the informed consent from (ICF).
  • Very advanced head and neck cancer aged more than 19.
  • Longest distance of the tumor is bigger than 1 cm and capable of Intratumoral injection.
  • Baseline ECOG Performance Status 0, 1 or 2.
  • Have a life expectancy more than 6 months.

Exclusion Criteria:

  • Have no history of prior anticancer treatment.
  • Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.Subject who have participated in a clinical trial of an treatment vaccine or immunotherapy in an year.
  • Have a tumor which is near a main vessel that can be occured embolism after injection or which has hypervascularity.
  • Patients currently receiving anticancer immuno-therapies Patients who have received prior treatment with an stem cell therapy.
  • Have autoimmune disease (multiple sclerosis, systemic lupus erythromatosis, thyroiditis, psoriasis, inflammatory bowel diseases etc.).
  • Have Graft rejection reaction such as GVHD.
  • Have immunodeficiency disease.
  • Leukocytes< 3.0 x109/L.
  • Absolute neutrophil count < 1.5x109/L.
  • Platelet count < 100 x 109/L.
  • Have known positive test for hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV).
  • Alanine Aminotransferase (ALT) > 2.5xUNL.
  • Aspartate Aminotransferase (AST)> 2.5xUNL.
  • Total Bilirubin> UNL.
  • Have blood Creatinine> UNL.
  • Known allergy to IL-12 or the excipient(s) of the study medication including fetal bovine serum.
  • Second primary cancer Metastatic brain tumor or meningioma.
  • Have a tumor near a main artery.
  • Uncontrolled hypertension.
  • Uncontrolled diabetes uncontrolled (arrhythmia).
  • Heart failure (more than NYHA Functional Class II); unstable coronary artery disease; myocardial infarction within 6 months.
  • Child-Pugh Class C hepatic impairment.
  • Severe renal impairment (creatinine clearance < 30 ml/min) or on dialysis.
  • Have active infection or history of recurrent infection.
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
  • Are considered ineligible by the investigator due to a mental disease or CNS disease.
  • Administration of any other tumor therapy, including chemotherapy and radiotherapy within 4 weeks(6 weeks in case of nitrosoureas and mytomycin C) before the beginning of study treatment.
  • Patients receiving chronic, systemic treatment with immunosuppressive agent(steroid) or immuno-modulator within 2 weeks prior to screening.
  • Have participated in another clinical trial within 30 days prior to dosing.

Sites / Locations

  • Seoul St.Mary's Hospital of the Catholic University of Korea

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GX-051

Arm Description

GX-051 intratumoral injection

Outcomes

Primary Outcome Measures

MTD after GX-051 intratumoral injection

Secondary Outcome Measures

Adverse events after GX-051 intratumoral injection
Anti-tumor response by RECIST 1.1 on computed tomography
Response Evaluation Criteria in Solid Tumors (RECIST) are used to determine objective clinical response. Complete Rresponse (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% decrease in the target lesions, progressive disease (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Changes of INF-γ and IL-12 levels in blood comparing to the baseline after GX-051 intratumoral injection
unit: pg/ml
Changes of immune cell distribution in tumor tissue after GX-051 intratumoral injection
We will analyze immune cells such as CD4+ T cell, CD8+ T cell, NK cell by FACS analysis on day 1(baseline), day 29(end of treatment) and day 57(follow up)
Evaluation of antibody generation against IL-12 which is active ingredient of GX-051
We will analyze anti-IL-12 antibody in blood by ELISA on the screening visit and the follw up visit. Result will report as existence or absence of the anti-body .
Evaluation of long term safety examined by vital sign, physical examination, clinical laboratory tests, CT etc
Safety profile would be examined by vital sign, physical examination, clinical laboratory tests, CT etc

Full Information

First Posted
February 27, 2014
Last Updated
April 29, 2015
Sponsor
Genexine, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02079324
Brief Title
Genetically Modified Mesenchymal Stem Cell Theraopeutic Against Head and Neck Cancer
Acronym
GX-051
Official Title
A Single Center, Open-Label, Accelerated Titration, Dose-Escalating, Phase Ι Study to Evaluate the Safety and Tolerability of IT Injection GX-051, Stem Cell Based Gene Therapeutics in Patients With Very Advanced Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genexine, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research is to evaluate MTD, Safety and efficacy of GX-051 after intratumoral injection in head and neck cancer patience.
Detailed Description
The primary purpose of the study is to determine MTD(Maximum Tolerable Dose) of GX-051 administered in tumor. The second purpose is to evaluate safety and efficacy of GX-051.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
head and neck cancer, gene therapy, stem cell therapy, immunotherappy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GX-051
Arm Type
Experimental
Arm Description
GX-051 intratumoral injection
Intervention Type
Biological
Intervention Name(s)
GX-051
Intervention Description
intratumoral injection
Primary Outcome Measure Information:
Title
MTD after GX-051 intratumoral injection
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Adverse events after GX-051 intratumoral injection
Time Frame
2 months
Title
Anti-tumor response by RECIST 1.1 on computed tomography
Description
Response Evaluation Criteria in Solid Tumors (RECIST) are used to determine objective clinical response. Complete Rresponse (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% decrease in the target lesions, progressive disease (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time Frame
2 months
Title
Changes of INF-γ and IL-12 levels in blood comparing to the baseline after GX-051 intratumoral injection
Description
unit: pg/ml
Time Frame
2 months
Title
Changes of immune cell distribution in tumor tissue after GX-051 intratumoral injection
Description
We will analyze immune cells such as CD4+ T cell, CD8+ T cell, NK cell by FACS analysis on day 1(baseline), day 29(end of treatment) and day 57(follow up)
Time Frame
2 months
Title
Evaluation of antibody generation against IL-12 which is active ingredient of GX-051
Description
We will analyze anti-IL-12 antibody in blood by ELISA on the screening visit and the follw up visit. Result will report as existence or absence of the anti-body .
Time Frame
2 months
Title
Evaluation of long term safety examined by vital sign, physical examination, clinical laboratory tests, CT etc
Description
Safety profile would be examined by vital sign, physical examination, clinical laboratory tests, CT etc
Time Frame
17 monthes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are capable of understanding and complying with the requirements of the study and have signed the informed consent from (ICF). Very advanced head and neck cancer aged more than 19. Longest distance of the tumor is bigger than 1 cm and capable of Intratumoral injection. Baseline ECOG Performance Status 0, 1 or 2. Have a life expectancy more than 6 months. Exclusion Criteria: Have no history of prior anticancer treatment. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.Subject who have participated in a clinical trial of an treatment vaccine or immunotherapy in an year. Have a tumor which is near a main vessel that can be occured embolism after injection or which has hypervascularity. Patients currently receiving anticancer immuno-therapies Patients who have received prior treatment with an stem cell therapy. Have autoimmune disease (multiple sclerosis, systemic lupus erythromatosis, thyroiditis, psoriasis, inflammatory bowel diseases etc.). Have Graft rejection reaction such as GVHD. Have immunodeficiency disease. Leukocytes< 3.0 x109/L. Absolute neutrophil count < 1.5x109/L. Platelet count < 100 x 109/L. Have known positive test for hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV). Alanine Aminotransferase (ALT) > 2.5xUNL. Aspartate Aminotransferase (AST)> 2.5xUNL. Total Bilirubin> UNL. Have blood Creatinine> UNL. Known allergy to IL-12 or the excipient(s) of the study medication including fetal bovine serum. Second primary cancer Metastatic brain tumor or meningioma. Have a tumor near a main artery. Uncontrolled hypertension. Uncontrolled diabetes uncontrolled (arrhythmia). Heart failure (more than NYHA Functional Class II); unstable coronary artery disease; myocardial infarction within 6 months. Child-Pugh Class C hepatic impairment. Severe renal impairment (creatinine clearance < 30 ml/min) or on dialysis. Have active infection or history of recurrent infection. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study. Are considered ineligible by the investigator due to a mental disease or CNS disease. Administration of any other tumor therapy, including chemotherapy and radiotherapy within 4 weeks(6 weeks in case of nitrosoureas and mytomycin C) before the beginning of study treatment. Patients receiving chronic, systemic treatment with immunosuppressive agent(steroid) or immuno-modulator within 2 weeks prior to screening. Have participated in another clinical trial within 30 days prior to dosing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minsik Kim, M.D.
Organizational Affiliation
Seoul St.Mary's Hospital of the Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hyun-Tak Jin, ph.D.
Organizational Affiliation
Genexine, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Seoul St.Mary's Hospital of the Catholic University of Korea
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Genetically Modified Mesenchymal Stem Cell Theraopeutic Against Head and Neck Cancer

We'll reach out to this number within 24 hrs