Trial Outcomes & Findings for Adoptive Transfer of iNKT Cells for Treating Patients With Relapsed/Advanced HCC (NCT NCT03175679)
NCT ID: NCT03175679
Last Updated: 2024-09-19
Results Overview
Defined as signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
Results posted on
2024-09-19
Participant Flow
This study enrolled patients diagnosed of HCC in the stage of BCLC B or C. But they don't have severe dysfunction of liver, kidney, heart and lung. Expected survival is more than 12weeks.
A total of 10 patients were recruited in this study from April 2017 to May 2018. Patient 1-8 received cell transfusion in stages according to the plan of 10%，30%，60% of them were used per infusion every other day, and patient 9 and 10 infused all of the cells at one-time.
Participant milestones
| Measure |
iNKT Cell Loading Dose:3x10^7/m2
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：3x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:6x10^7/m2
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：6x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:9x10^7/m2
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：9x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:1x10^10/m2.
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：1x10\^10/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
1
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adoptive Transfer of iNKT Cells for Treating Patients With Relapsed/Advanced HCC
Baseline characteristics by cohort
| Measure |
iNKT Cell Loading Dose:3x10^7/m2
n=3 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：3x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:6x10^7/m2
n=3 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：6x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:9x10^7/m2
n=3 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：9x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:1x10^10/m2
n=1 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：1x10\^10/m\^2 Cells.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
50 years
n=5 Participants
|
51 years
n=7 Participants
|
52 years
n=5 Participants
|
53 years
n=4 Participants
|
51.5 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
BCLC (Barcelona Clinic Liver Cancer ) stage
BCLC stage B
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
BCLC (Barcelona Clinic Liver Cancer ) stage
BCLC stage C
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.Population: Adverse events defined as the occurrence of toxicity events within 4 weeks after iNKT cells infusion. The severity of adverse events were divided into 5 levels.
Defined as signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.
Outcome measures
| Measure |
iNKT Cell Loading Dose:3x10^7/m2
n=3 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：3x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:6x10^7/m2
n=3 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：6x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:9x10^7/m2
n=3 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：9x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:1x10^10/m2
n=1 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：1x10\^10/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
|---|---|---|---|---|
|
Number of Adverse Events
Grade 1
|
12 events
|
2 events
|
8 events
|
4 events
|
|
Number of Adverse Events
Grade 2
|
0 events
|
1 events
|
1 events
|
1 events
|
|
Number of Adverse Events
Grade 3
|
2 events
|
0 events
|
1 events
|
0 events
|
|
Number of Adverse Events
Grade 4
|
0 events
|
0 events
|
0 events
|
0 events
|
|
Number of Adverse Events
Grade 5
|
1 events
|
1 events
|
2 events
|
1 events
|
SECONDARY outcome
Timeframe: Through study completion, an average of 12 months.PFS is the time that passes from the date that patient enrolled in the clinical trial and the date on which HCC progresses or the date on which the patient dies. HCC progression was evaluated by imaging according to the irRC standard. Progression is defined as a ≥25% increase in the nadir of the sum of target lesions.
Outcome measures
| Measure |
iNKT Cell Loading Dose:3x10^7/m2
n=3 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：3x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:6x10^7/m2
n=3 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：6x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:9x10^7/m2
n=3 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：9x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:1x10^10/m2
n=1 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：1x10\^10/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
|---|---|---|---|---|
|
Progression-Free Survival (PFS)
<6months
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Progression-Free Survival (PFS)
6-12months
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Progression-Free Survival (PFS)
>12months
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeks, 8 weeks, 12 weeks and 24 weeks after cell infusion.Disease stabilization (SD) or progressive diseasee (PD) were valuated by imaging according to the irRC standard. Complete response (CR): Disappearance of all lesions; Partial response (PR): ≥50% decrease from baseline; SD: Neither CR or PD is met; PD≥25% increase in the nadir of the sum of target lesions.
Outcome measures
| Measure |
iNKT Cell Loading Dose:3x10^7/m2
n=3 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：3x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:6x10^7/m2
n=3 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：6x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:9x10^7/m2
n=3 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：9x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:1x10^10/m2
n=1 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：1x10\^10/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Stabilized (SD) or Progressive (PD) Disease.
At 4th week after cell infusion · SD
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Stabilized (SD) or Progressive (PD) Disease.
At 4th week after cell infusion · PD
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Stabilized (SD) or Progressive (PD) Disease.
At 8th week after cell infusion · SD
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Stabilized (SD) or Progressive (PD) Disease.
At 8th week after cell infusion · PD
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Stabilized (SD) or Progressive (PD) Disease.
At 12th week after cell infusion · SD
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Stabilized (SD) or Progressive (PD) Disease.
At 12th week after cell infusion · PD
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Stabilized (SD) or Progressive (PD) Disease.
At 24th week after · SD
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Stabilized (SD) or Progressive (PD) Disease.
At 24th week after · PD
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study completion, up to 20 months.OS is the time that passes from the date that patient enrolled in the clinical trial and the date on which the patient dies, according to the irRC standard.
Outcome measures
| Measure |
iNKT Cell Loading Dose:3x10^7/m2
n=3 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：3x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:6x10^7/m2
n=3 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：6x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:9x10^7/m2
n=3 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：9x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:1x10^10/m2
n=1 Participants
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：1x10\^10/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
|---|---|---|---|---|
|
Overall Survival (OS)
<6months
|
1 participants
|
0 participants
|
2 participants
|
0 participants
|
|
Overall Survival (OS)
6-12months
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Overall Survival (OS)
>12months
|
2 participants
|
2 participants
|
1 participants
|
0 participants
|
Adverse Events
iNKT Cell Loading Dose:3x10^7/m2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
iNKT Cell Loading Dose:6x10^7/m2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
iNKT Cell Loading Dose:9x10^7/m2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
iNKT Cell Loading Dose:1x10^10/m2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
iNKT Cell Loading Dose:3x10^7/m2
n=3 participants at risk
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：3x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:6x10^7/m2
n=3 participants at risk
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：6x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:9x10^7/m2
n=3 participants at risk
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：9x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:1x10^10/m2
n=1 participants at risk
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：1x10\^10/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Cirrhosis and upper gastrointestinal bleeding
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
33.3%
1/3 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
66.7%
2/3 • Number of events 2 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
|
Gastrointestinal disorders
Refractory bile duct infection and toxic megacolon
|
33.3%
1/3 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
|
Gastrointestinal disorders
Spontaneous rupture of the tumor
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
100.0%
1/1 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
Other adverse events
| Measure |
iNKT Cell Loading Dose:3x10^7/m2
n=3 participants at risk
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：3x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:6x10^7/m2
n=3 participants at risk
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：6x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:9x10^7/m2
n=3 participants at risk
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：9x10\^7/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
iNKT Cell Loading Dose:1x10^10/m2
n=1 participants at risk
Autologous in vitro expanded iNKT cells in conjunction with IL-2 and along with lymphodepleting chemotherapy (Tegafur) will be administered to patients with advanced HCC.
iNKT Cell Loading Dose：1x10\^10/m2.
IL-2: IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
Tegafur: Tegafur will be given at a dose of 40\~60 mg bis in die (BID) 2 weeks.
|
|---|---|---|---|---|
|
Immune system disorders
Chills
|
66.7%
2/3 • Number of events 2 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
|
Immune system disorders
Fever
|
100.0%
3/3 • Number of events 3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
|
Gastrointestinal disorders
Pain
|
33.3%
1/3 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
33.3%
1/3 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
33.3%
1/3 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
|
Blood and lymphatic system disorders
Decreased platelet count
|
33.3%
1/3 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
33.3%
1/3 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
33.3%
1/3 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
100.0%
1/1 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
|
Blood and lymphatic system disorders
Decreased neutrophil count
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
100.0%
1/1 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
|
Blood and lymphatic system disorders
Decreased white blood cell count
|
33.3%
1/3 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
33.3%
1/3 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
100.0%
1/1 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
|
Hepatobiliary disorders
Increased blood bilirubin level
|
100.0%
3/3 • Number of events 3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
33.3%
1/3 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
100.0%
3/3 • Number of events 3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
|
Hepatobiliary disorders
Increased alanine transaminase level
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
33.3%
1/3 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
100.0%
1/1 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
|
Hepatobiliary disorders
Increased aspartate transaminase level
|
33.3%
1/3 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
66.7%
2/3 • Number of events 2 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
100.0%
1/1 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous induration
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
33.3%
1/3 • Number of events 1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/3 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
0.00%
0/1 • During the first 12 weeks, participants were assessed for adverse events every 2-4 weeks after infusion; after the first 12 weeks, participants were assessed for adverse events every 3 months, up to 20 months.
The severity of adverse events were divided into 5 levels according to the National Cancer Institute (NCI) Common Terminology Standard for Adverse Events (CTCAE) version 4.03.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place