|
Cohort1: dose level 1_High-dose IL-2
|
| Administration route |
intravenous infusion |
| Dosage |
1E9~1E10 cells/kg |
| Donor type |
Autologous |
| Pts |
8 |
| Age |
Adult, Older_Adult |
| Lymph depletion |
Yes |
| Outcome |
2/8(CR); 4/8(PR); 1/8(SD); 0(PD) |
| Adverse reactions |
1/8(All-cause mortality); 7/8(Cardiac disorders; General disorders; Infections and infestations; Nervous system disorders; Renal and urinary disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders) |
|
|
Cohort2: dose level 1_High-dose IL-2 Retreat
|
| Administration route |
intravenous infusion |
| Dosage |
1E9~1E10 cells/kg |
| Donor type |
Autologous |
| Pts |
3 |
| Age |
Adult, Older_Adult |
| Lymph depletion |
Yes |
| Outcome |
3/3(CR) |
| Adverse reactions |
1/3(Metabolism and nutrition disorders) |
|
|
Cohort3: dose level 2
|
| Administration route |
intravenous infusion |
| Dosage |
0.5E7 cells/kg |
| Donor type |
Autologous |
| Pts |
2 |
| Age |
Adult, Older_Adult |
| Lymph depletion |
Yes |
| Outcome |
2/2(CR) |
| Adverse reactions |
2/2(Cardiac disorders; Nervous system disorders) |
|
|
Cohort4: dose level 3
|
| Administration route |
intravenous infusion |
| Dosage |
2.5E6 cells/kg |
| Donor type |
Autologous |
| Pts |
5 |
| Age |
Adult, Older_Adult |
| Lymph depletion |
Yes |
| Outcome |
3/5(CR); 1/5(PD) |
| Adverse reactions |
1/5(All-cause mortality); 3/5(Cardiac disorders; General disorders; Metabolism and nutrition disorders; Nervous system disorders; Respiratory, thoracic and mediastinal disorders) |
|
|
Cohort5: dose level 4
|
| Administration route |
intravenous infusion |
| Dosage |
1E6 cells/kg |
| Donor type |
Autologous |
| Pts |
6 |
| Age |
Adult, Older_Adult |
| Lymph depletion |
Yes |
| Outcome |
3/6(CR); 2/6(PR) |
| Adverse reactions |
2/6(Gastrointestinal disorders; Nervous system disorders; Vascular disorders) |
|
|
Cohort6: dose level 4_Reduced Chemo
|
| Administration route |
intravenous infusion |
| Dosage |
1E6 cells/kg |
| Donor type |
Autologous |
| Pts |
7 |
| Age |
Adult, Older_Adult |
| Lymph depletion |
Yes |
| Outcome |
2/7(CR); 3/7(PR); 2/7(PD) |
| Adverse reactions |
2/7(General disorders; Nervous system disorders) |
|
|
Cohort7: dose level 5_Reduced Chemo
|
| Administration route |
intravenous infusion |
| Dosage |
2E6 cells/kg |
| Donor type |
Autologous |
| Pts |
10 |
| Age |
Adult, Older_Adult |
| Lymph depletion |
Yes |
| Outcome |
6/10(CR); 1/10(PR); 1/10(SD); 2/10(PD) |
| Adverse reactions |
7/10(Blood and lymphatic system disorders; Cardiac disorders; Gastrointestinal disorders; Infections and infestations; Musculoskeletal and connective tissue disorders; Nervous system disorders; Renal and urinary disorders) |
|
|
Cohort8: dose level 6_Reduced Chemo
|
| Administration route |
intravenous infusion |
| Dosage |
6E6 cells/kg |
| Donor type |
Autologous |
| Pts |
1 |
| Age |
Adult, Older_Adult |
| Lymph depletion |
Yes |
| Outcome |
1/1(PD) |
| Adverse reactions |
1/1(Nervous system disorders; Respiratory, thoracic and mediastinal disorders) |
|
|
Cohort9: dose level 7_Moderate Chemo
|
| Administration route |
intravenous infusion |
| Dosage |
2E6 cells/kg |
| Donor type |
Autologous |
| Pts |
2 |
| Age |
Adult, Older_Adult |
| Lymph depletion |
Yes |
| Outcome |
2/2(CR) |
| Adverse reactions |
2/2(Blood and lymphatic system disorders; Cardiac disorders; Gastrointestinal disorders; General disorders; Nervous system disorders) |
|
|
Cohort10: dose level 8_9-12 Days Culture
|
| Administration route |
intravenous infusion |
| Dosage |
2E6 cells/kg |
| Donor type |
Autologous |
| Pts |
2 |
| Age |
Adult, Older_Adult |
| Lymph depletion |
Yes |
| Outcome |
2/2(CR) |
| Adverse reactions |
2/2(Cardiac disorders; Infections and infestations; Nervous system disorders; Respiratory, thoracic and mediastinal disorders) |
|