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

Gene symbol TP53 Synonyms BCC7, BMFS5, LFS1, P53, TRP53 Type of gene protein-coding
Gene perturbation-related omics dataset PerturbAtlas | PertOrg
Description tumor protein p53

GTO ID GTC3963
Disease Melanoma | Cholangiocarcinoma | Esophageal Cancer | Breast Cancer | Salivary Gland Adenocarcinoma
Altered gene gp100|P53
Therapeutic/Target gene Target gene
TherapyTCR-T cell
Treatment gp100/P53 TCR-T cells
HLAHLA-A*02
Recruitment statusUnknown
TitleDevelopment of human anti-murine T-cell receptor antibodies in both responding and nonresponding patients enrolled in TCR gene therapy trials
Company sponsorNational Cancer Institute (NCI)
Vector information
Vectorretrovirus
Vector typeMSGV1-based retrovirus

Clinical Result

Cohort 1
Administration route intravenous infusion
Dosage 40 mg/kg/day continuous on days 1-4 of a 28-day cycle, for two cycles
Pts 35
Outcome 1/35(PR); 21/35(PD); 12/35(SD)
Adverse reactions 1/35(Arthralgia); 1/35(Anemia); 1/35(Upper abdominal pain)
References PMID: 21138872
Cohort 2
Administration route intravitreal injection
Dosage 0.3 mg
Pts 133
Outcome the proportions of subjects with an improvement of >= 10 letters: at week 102 was 38.3% (41/107). Improvement of >=15 letters: from baseline to week 54 were 16.5% (22/133); at week 102 was 23.4%(25/107). The proportion of subjects with a decrease in the degree of retinopathy by >= 2 steps: at week 54 was 10.2%; at week 102 was 16.3%. The proportion of subjects with a >= 25% decrease in retinal thickness: at week 54 was 31.7% (39/123); at week 102 was 40.4%(40/99). A >= 50% decrease in retinal thickness: at week 54 was 14.6% (18/123); at week 102 was 19.2%(19/99).
Adverse reactions 2/144(angina pectoris; coronary artery disease); 1/144(vitreous hemorrhage); 32/144(conjunctival hemorrhage); 16/144(diabetic retinal edema)
References PMID: 21138872
Cohort 3
Administration route intravitreal injection
Dosage 0.3 mg
Pts 61
Outcome The mean change in visual acuity decreased by 10.3 letters for up to 199 weeks (62-199 weeks; mean 140 weeks) during follow-up.
Adverse reactions 12/61(retinal hemorrhage; anterior chamber inflammation; macular degeneration; floaters; photopsia; retinal vessel aneurysm; vitreous hemorrhage; ocular hypertension; arteriosclerosis obliterans; hypertension)
References PMID: 21138872
Cohort 4
Administration route intravitreal injection
Dosage 3 mg/100 microL (every 6 weeks for minimum of 6 injections)
Pts 5
Outcome These two patients had progressive decrease in retinal hard exudate and reduction in central retinal thickness measured by optical coherence tomography. One of these two patients had improvement in visual acuity of 3 lines.
Adverse reactions 1/5(tractional retinal detachment); 3/5(transient postinjection hypotony in two eyes)
References PMID: 21138872
Cohort 5
Administration route infusion
Dosage 0.1~8.6E10 cells
Donor type autologous
Pts 17
Lymph depletion Yes
Outcome 2/17(PR); 15/17(SD)
Adverse reactions not mentioned
References PMID: 21138872
Cohort 6
Administration route injection
Dosage 0.266~2.66E11 cells
Donor type Allogeneic
Pts 15
Outcome 1/15(PR)
Adverse reactions 1(septicemia)
References PMID: 21138872
Cohort1: Eye001
Administration route intravitreal injection
Dosage 3 mg/100 μl, 3 times at 28-day intervals
Pts 10
Outcome 87.5% of patients had stabilized (<0 lines increase) or improved vision; 60% of patients showed a 3 line improvement of vision on the ETDRS chart at 3 months
Adverse reactions vitreous floaters; mild anterior chamber inflammation; ocular irritation; increased intraocular pressure; intraocular air; vitreous haze; subconjunctival hemorrhage; eye pain; lid edema/erythema; dry eye; conjunctival injection
References PMID: 21138872
Cohort2: Eye001_Photodynamic Therapy
Administration route intravitreal injection
Dosage 3 mg/100 μl, 3 times at 28-day intervals
Pts 11
Outcome 90% of patients had stabilized (<0 lines increase) or improved vision; 60% of patients showed a 3 line improvement of vision on the ETDRS chart at 3 months
Adverse reactions ptosis; mild anterior chamber inflammation; corneal abrasion; eye pain; foreign body sensation; chemosis; subconjunctival hemorrhage; vitreous prolapse
References PMID: 21138872
Cohort1: dose level 1
Administration route intravitreal injection
Dosage 0.3 mg
Pts 295
Age Adult, Older_Adult
Adverse reactions eye pain; vitreous floaters; punctate keratitis; cataracts; vitreous opacities; anterior-chamber inflammation; visual disturbance; eye discharge; corneal edema
References PMID: 21138872
Cohort2: dose level 2
Administration route intravitreal injection
Dosage 1 mg
Pts 301
Age Adult, Older_Adult
Adverse reactions eye pain; vitreous floaters; punctate keratitis; cataracts; vitreous opacities; anterior-chamber inflammation; visual disturbance; eye discharge; corneal edema
References PMID: 21138872
Cohort3: dose level 3
Administration route intravitreal injection
Dosage 3 mg
Pts 296
Age Adult, Older_Adult
Adverse reactions eye pain; vitreous floaters; punctate keratitis; cataracts; vitreous opacities; anterior-chamber inflammation; visual disturbance; eye discharge; corneal edema
References PMID: 21138872
Cohort1: dose level 1
Administration route intravitreal injection
Dosage 0.3 mg
Pts 44
Adverse reactions 6/44(Serious Adverse reactions)
References PMID: 21138872
Cohort2: dose level 2
Administration route intravitreal injection
Dosage 1 mg
Pts 44
Adverse reactions 2/44(Serious Adverse reactions)
References PMID: 21138872
Cohort3: dose level 3
Administration route intravitreal injection
Dosage 3 mg
Pts 42
Adverse reactions 13/42(Serious Adverse reactions)
References PMID: 21138872
Cohort 15
Administration route injection
Dosage 0.266~2.66E11 cells
Donor type Allogeneic
Pts 15
Outcome 1/15(PR)
Adverse reactions 1(septicemia)
References PMID: 21138872
Cohort 16
Administration route intravitreal injection
Dosage 3 mg/100 microL (every 6 weeks for minimum of 6 injections)
Pts 5
Outcome These two patients had progressive decrease in retinal hard exudate and reduction in central retinal thickness measured by optical coherence tomography. One of these two patients had improvement in visual acuity of 3 lines.
Adverse reactions 1/5(tractional retinal detachment); 3/5(transient postinjection hypotony in two eyes)
References PMID: 21138872
Cohort1: dose level 1_RB006_RB007
Administration route intravenous infusion
Dosage 15 mg
Pts 6
Adverse reactions No serious clinical adverse events
References PMID: 21138872
Cohort2: dose level 2_RB006_RB007
Administration route intravenous infusion
Dosage 30 mg
Pts 6
Adverse reactions No serious clinical adverse events
References PMID: 21138872
Cohort3: dose level 3_RB006_RB007
Administration route intravenous infusion
Dosage 50 mg
Pts 8
Adverse reactions No serious clinical adverse events
References PMID: 21138872
Cohort4: dose level 4_RB006_RB007
Administration route intravenous infusion
Dosage 75mg
Pts 8
Adverse reactions No serious clinical adverse events
References PMID: 21138872
Cohort5: dose level 1_RB006_placebo
Administration route intravenous infusion
Dosage 15 mg
Pts 3
Adverse reactions No serious clinical adverse events
References PMID: 21138872
Cohort6: dose level 2_RB006_placebo
Administration route intravenous infusion
Dosage 30 mg
Pts 3
Adverse reactions No serious clinical adverse events
References PMID: 21138872
Cohort7: dose level 3_RB006_placebo
Administration route intravenous infusion
Dosage 50 mg
Pts 4
Adverse reactions No serious clinical adverse events
References PMID: 21138872
Cohort8: dose level 4_RB006_placebo
Administration route intravenous infusion
Dosage 75mg
Pts 4
Adverse reactions No serious clinical adverse events
References PMID: 21138872
Cohort1: MART-1 TCR-T
Administration route infusion
Dosage 0.1~8.6E10 cells
Donor type autologous
Pts 10
Lymph depletion Yes
Outcome 1/10(CR); 1/10(PR); 8/10(SD)
Adverse reactions not mentioned
References PMID: 21138872
Cohort2: gp100 TCR-T
Administration route infusion
Dosage 0.1~8.6E10 cells
Donor type autologous
Pts 8
Lymph depletion Yes
Outcome 8/8(SD)
Adverse reactions not mentioned
References PMID: 21138872
Cohort1: melanoma_gp100 TCR-T
Administration route infusion
Dosage 0.18~11E10 mcells
Donor type autologous
Pts 18
Lymph depletion Yes
Outcome 1/18(CAR); 2/18(PR); 16/18(SD)
Adverse reactions No serious clinical adverse events
References PMID: 21138872
Cohort2: Cholangiocarcinoma_P53 TCR-T
Administration route infusion
Dosage 0.8E9 cells
Donor type autologous
Pts 1
Lymph depletion Yes
Outcome 1/1(SD)
Adverse reactions No serious clinical adverse events
References PMID: 21138872
Cohort3: esophageal cancer_P53 TCR-T
Administration route infusion
Dosage 1.2E9 mcells
Donor type autologous
Pts 1
Lymph depletion Yes
Outcome 1/1(SD)
Adverse reactions No serious clinical adverse events
References PMID: 21138872
Cohort4: melanoma_p53 TCR-T
Administration route infusion
Dosage 2.2~27.7E9 mcells
Donor type autologous
Pts 2
Lymph depletion Yes
Outcome 2/2(SD)
Adverse reactions No serious clinical adverse events
References PMID: 21138872
Cohort5: breast cancer_P53 TCR-T
Administration route infusion
Dosage 0.8~9.2E9 mcells
Donor type autologous
Pts 4
Lymph depletion Yes
Outcome 4/4(SD)
Adverse reactions No serious clinical adverse events
References PMID: 21138872
Cohort6: Salivary gland adenocarcinoma_P53 TCR-T
Administration route infusion
Dosage 0.5E9 cells
Donor type autologous
Pts 1
Lymph depletion Yes
Outcome 1/1(PR)
Adverse reactions No serious clinical adverse events
References PMID: 21138872
Cohort7: Small bowel adenocarcinoma_P53 TCR-T
Administration route infusion
Dosage 3.7E9 mcells
Donor type autologous
Pts 1
Lymph depletion Yes
Outcome 1/1(SD)
Adverse reactions No serious clinical adverse events
References PMID: 21138872
Cohort 34
Administration route None
References PMID: 21138872

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