Basic Information

Gene symbol E6 Synonyms None Type of gene protein-coding
Description protein E6*;transforming protein E6

GTO ID GTC0221
Trial ID NCT02280811
Disease Cervical Cancer | Anal Canal Cancer | Vaginal Cancer | Oropharyngeal Cancer | Penile Cancer
Altered gene E6
Therapeutic/Target gene Target gene
TherapyTCR-T cell
Treatment HPV-16 E6 TCR-T cells
HLAHLA-A*02:01
PhasePhase1|Phase2
Recruitment statusCompleted
TitleA Phase I/II Study of T Cell Receptor Gene Therapy Targeting HPV-16 E6 for HPV-Associated Cancers
Year2014
CountryUnited States
Company sponsorNational Cancer Institute (NCI)
Other ID(s)150005|15-C-0005
Vector information
Vectorretrovirus
Vector typeE6 TCR retrovirus vector
Vector production methodPatients underwent leukapheresis to acquire peripheral blood mononuclear cells. Peripheral blood mononuclear cells were stimulated with 50 ng/mL soluble anti-CD3 (OKT3; Ortho-Biotech, Bridgewater, NJ) and 300 IU recombinant interleukin-2 (IL-2). The cells were transduced with E6 TCR retrovirus, a gamma retrovirus supernatant manufactured by the National Cancer Institute Surgery Branch Vector Production Facility (Bethesda, MD). Cells were expanded with a rapid expansion protocol.

Clinical Result

Cohort1: dose level 1
Administration route infusion
Dosage 1E9 cells
Donor type autologous
Pts 1
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 1/1(SD)
Adverse reactions No serious clinical adverse events
References PMID: 31408414
Cohort2: dose level 2
Administration route infusion
Dosage 1E10 cells
Donor type autologous
Pts 2
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 2/2(PD)
Adverse reactions 1/2(Respiratory, thoracic and mediastinal disorders)
References PMID: 31408414
Cohort3: dose level 3
Administration route infusion
Dosage 1E11 cells
Donor type autologous
Pts 1
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 1/1(SD)
Adverse reactions No serious clinical adverse events
References PMID: 31408414
Cohort4: dose level 4
Administration route infusion
Dosage 1~2E11 cells
Donor type autologous
Pts 6
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 2/6(PR); 2/6(PD); 2/6(SD)
Adverse reactions 2/6(Gastrointestinal disorders; Infections and infestations)
References PMID: 31408414
Cohort5: dose level 5
Administration route infusion
Dosage maximum tolerated dose
Donor type autologous
Pts 2
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 2/2(PD)
Adverse reactions 2/2(Infections and infestations)
References PMID: 31408414

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