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

Genexine

Status and phase

Completed

Phase 1

Conditions

Head and Neck Cancer

Treatments

Biological: GX-051

Study type

Interventional

Funder types

Industry

Identifiers

NCT02079324

GX-051_HNC_1

Details and patient eligibility

About

The purpose of this research is to evaluate MTD, Safety and efficacy of GX-051 after intratumoral injection in head and neck cancer patience.

Full 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.

Enrollment

12 patients

Sex

All

Ages

19+ years old

Volunteers

No 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.