|
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:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
Cohort1: dose level 1
|
| Administration route |
intravitreal injection |
| Dosage |
0.3 mg |
| Pts |
44 |
| Adverse reactions |
6/44(Serious Adverse reactions) |
| References |
PMID:
24242861
|
|
|
Cohort2: dose level 2
|
| Administration route |
intravitreal injection |
| Dosage |
1 mg |
| Pts |
44 |
| Adverse reactions |
2/44(Serious Adverse reactions) |
| References |
PMID:
24242861
|
|
|
Cohort3: dose level 3
|
| Administration route |
intravitreal injection |
| Dosage |
3 mg |
| Pts |
42 |
| Adverse reactions |
13/42(Serious Adverse reactions) |
| References |
PMID:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
Cohort1: dose level 1_RB006_RB007
|
| Administration route |
intravenous infusion |
| Dosage |
15 mg |
| Pts |
6 |
| Adverse reactions |
No serious clinical adverse events |
| References |
PMID:
24242861
|
|
|
Cohort2: dose level 2_RB006_RB007
|
| Administration route |
intravenous infusion |
| Dosage |
30 mg |
| Pts |
6 |
| Adverse reactions |
No serious clinical adverse events |
| References |
PMID:
24242861
|
|
|
Cohort3: dose level 3_RB006_RB007
|
| Administration route |
intravenous infusion |
| Dosage |
50 mg |
| Pts |
8 |
| Adverse reactions |
No serious clinical adverse events |
| References |
PMID:
24242861
|
|
|
Cohort4: dose level 4_RB006_RB007
|
| Administration route |
intravenous infusion |
| Dosage |
75mg |
| Pts |
8 |
| Adverse reactions |
No serious clinical adverse events |
| References |
PMID:
24242861
|
|
|
Cohort5: dose level 1_RB006_placebo
|
| Administration route |
intravenous infusion |
| Dosage |
15 mg |
| Pts |
3 |
| Adverse reactions |
No serious clinical adverse events |
| References |
PMID:
24242861
|
|
|
Cohort6: dose level 2_RB006_placebo
|
| Administration route |
intravenous infusion |
| Dosage |
30 mg |
| Pts |
3 |
| Adverse reactions |
No serious clinical adverse events |
| References |
PMID:
24242861
|
|
|
Cohort7: dose level 3_RB006_placebo
|
| Administration route |
intravenous infusion |
| Dosage |
50 mg |
| Pts |
4 |
| Adverse reactions |
No serious clinical adverse events |
| References |
PMID:
24242861
|
|
|
Cohort8: dose level 4_RB006_placebo
|
| Administration route |
intravenous infusion |
| Dosage |
75mg |
| Pts |
4 |
| Adverse reactions |
No serious clinical adverse events |
| References |
PMID:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
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:
24242861
|
|
|
Cohort 34
|
| Administration route |
None |
| References |
PMID:
24242861
|
|