Basic Information

Gene symbol tk

GTO ID GTC0077
Trial ID NCT00844623
Disease Hepatocellular Carcinoma
Altered gene tk
Therapeutic/Target gene Therapeutic gene
TherapyGene transfer
Treatment TK99UN
PhasePhase1
Recruitment statusCompleted
TitlePhase I Clinical Trial Of Gene Therapy For Hepatocellular Carcinoma By Intratumoral Injection Of TK99UN (An Adenoviral Vector Containing The Thymidine Kinase Of Herpes Simplex Virus)
Year2009
CountrySpain
Company sponsorClinica Universidad de Navarra, Universidad de Navarra
Other ID(s)TK99UN-HCC1
Vector information
Vectoradenovirus
ConstructAd.TK
Vector typefirst-generation, replication-defective adenoviral vector
Transgene/Inserted gene2.8-kb BglII/ BamHI fragment of pMK containing the HSV1-tk gene
Regulatory elementthe strong, nonselective cytomegalovirus (CMV) promoter; upstream of a polyadenylation signal (polyA)
Vector production methodpJM17 (containing the backbone of adenovirus serotype 5) and pMV60/TK were co-transfected into 293 cells (from the American Type Culture Collection, Manassas, VA)

Clinical Result

Cohort 1
Administration route intratumoral injection
Dosage 2E10~2E12 vp
Pts 10
Age Adult, Older_Adult
Outcome 0/10(PR); 60% of patients showed tumor stabilization of the injected lesion.
Adverse reactions Fever; Flu-like syndrome; Lymphopenia; Injection site pain; Abdominal pain; Leukopenia; Thrombocytopenia; Anemia; Vomiting; Encephalopathy; Edema; DiarrheaAscites; Hyperbilirubinemia; Hypertransaminasemia; Itching
References PMID: 20689572

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