Basic Information

Gene symbol PMEL Synonyms D12S53E, HMB-45, HMB45, ME20, ME20-M, ME20M, P1, P100, PMEL17, SI, SIL, SILV, gp100 Type of gene protein-coding
Description premelanosome protein

GTO ID GTC0042
Trial ID NCT00509496
Disease Metastatic Melanoma
Altered gene gp100
Therapeutic/Target gene Target gene
TherapyTCR-T cell
Treatment gp100:154-162 TCR-T cells
HLAHLA-A*02:01
PhasePhase2
Recruitment statusTerminated
TitlePhase II Study of Metastatic Melanoma Using Lymphodepleting Conditioning Followed by Infusion of Anti-gp100:154-162 TCR-Gene Engineered Lymphocytes
Year2007
CountryUnited States
Company sponsorNational Cancer Institute (NCI)
Other ID(s)070174|07-C-0174
Vector information
Vectorretrovirus
Transgene/Inserted geneDMF5 TCR-α cDNA; furin T2A cleavage sequence; DMF5 TCR-β cDNA
Viral genome modificationpMSGV1 is derived from pMSGV murine stem cell virus long terminal repeat containing an extended gag region and Kozak sequence. Vector pMSGV1 gp100(154)-AIB was produced by linking the TCR-α via an internal ribosome entry site (IRES) element followed by insertion of the TCR-β chain. Vector pMSGV DMF5 furin 2-A was generated by introducing DMF5 TCR-α cDNA, followed by a furin T2A cleavage sequence and DMF5 TCR-β.

Clinical Result

Cohort1: TCR PBLs
Administration route infusion
Dosage 0.18~1.1E10 cells
Donor type autologous
Pts 19
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 1/19(CR); 2/19(PR); 16/19(PD)
Adverse reactions 5/19(Cardiac disorders; Infections and infestations; Metabolism and nutrition disorders; Metabolism and nutrition disorders; Renal and urinary disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)
References PMID: 19451549
Cohort2: TCR TILs
Administration route infusion
Dosage 0.18~1.1E10 cells
Donor type autologous
Pts 2
Age Adult, Older_Adult
Lymph depletion Yes
Outcome 1/2(PR); 1/2(PD)
Adverse reactions none(grade 3 or higher)
References PMID: 19451549

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