Clinical trial · Interventional
Genetically Modified Mesenchymal Stem Cell Theraopeutic Against Head and Neck Cancer
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
NCT02079324CI-TRIAL-00094034GX-051completedPhase 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 research is to evaluate MTD, Safety and efficacy of GX-051 after intratumoral injection in head and neck cancer patience.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GX-051 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GX-051
- description
- GX-051 intratumoral injection
- interventionNames
- Biological: GX-051
Primary outcomes (1)
- measure
- MTD after GX-051 intratumoral injection
- timeFrame
- 2 months
Secondary outcomes (6)
- measure
- Adverse events after GX-051 intratumoral injection
- timeFrame
- 2 months
- measure
- Anti-tumor response by RECIST 1.1 on computed tomography
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.