Trial Outcomes & Findings for PD-1 Knockout Engineered T Cells for Metastatic Non-small Cell Lung Cancer (NCT NCT02793856)
NCT ID: NCT02793856
Last Updated: 2021-01-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Dose Escalation - Approximately 6 months
Results posted on
2021-01-12
Participant Flow
Participant milestones
| Measure |
Pre-A-One Cycle
Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.
A total of 2 x 10\^7/kg PD-1 Knockout T cells will be infused in one cycle which is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of one cycle of treatment.
Cyclophosphamide: To deplete Tregs before collecting peripheral blood
PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment
|
A - Two Cycles
Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.
A total of 1 x 10\^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.
Cyclophosphamide: To deplete Tregs before collecting peripheral blood
PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment
|
B- Two Cycles
Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.
A total of 2 x 10\^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.
Cyclophosphamide: To deplete Tregs before collecting peripheral blood
PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment
|
C- Two Cycles
Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.
A total of 4 x 10\^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.
Cyclophosphamide: To deplete Tregs before collecting peripheral blood
PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
4
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PD-1 Knockout Engineered T Cells for Metastatic Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Pre-A-One Cycle
n=2 Participants
Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.
A total of 2 x 10\^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of one cycle of treatment.
Cyclophosphamide: To deplete Tregs before collecting peripheral blood
PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment
|
A - Two Cycles
n=4 Participants
Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.
A total of 1 x 10\^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.
Cyclophosphamide: To deplete Tregs before collecting peripheral blood
PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment
|
B- Two Cycles
n=3 Participants
Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.
A total of 2 x 10\^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.
Cyclophosphamide: To deplete Tregs before collecting peripheral blood
PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment
|
C- Two Cycles
n=3 Participants
Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.
A total of 4 x 10\^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.
Cyclophosphamide: To deplete Tregs before collecting peripheral blood
PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment
|
Total
n=12 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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Continuous
|
55.5 years
n=5 Participants
|
56 years
n=7 Participants
|
55 years
n=5 Participants
|
53 years
n=4 Participants
|
54.5 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 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
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 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
|
|
Region of Enrollment
China
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
12 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Dose Escalation - Approximately 6 monthsOutcome measures
| Measure |
Pre-A Cohort
n=2 Participants
All adverse events are grade 1-2.
|
A Cohort
n=4 Participants
All adverse events are grade 1-2.
|
B Cohort
n=3 Participants
All adverse events are grade 1-2.
|
C Cohort
n=3 Participants
All adverse events are grade 1-2.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of Dose of PD-1 Knockout T Cells Using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in Patients
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."
Outcome measures
| Measure |
Pre-A Cohort
n=2 Participants
All adverse events are grade 1-2.
|
A Cohort
n=3 Participants
All adverse events are grade 1-2.
|
B Cohort
n=3 Participants
All adverse events are grade 1-2.
|
C Cohort
n=3 Participants
All adverse events are grade 1-2.
|
|---|---|---|---|---|
|
Number of Patients With Overall Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksResponse will be evaluated according to RECIST v1.1 for target lesions at Week 8：Complete Response (CR), Disappearance of all extranodal target lesions; Partial Response (PR) ≥ 30% decrease in the sum of diameters of target lesions; Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Disease control = CR +PR+SD
Outcome measures
| Measure |
Pre-A Cohort
n=2 Participants
All adverse events are grade 1-2.
|
A Cohort
n=3 Participants
All adverse events are grade 1-2.
|
B Cohort
n=3 Participants
All adverse events are grade 1-2.
|
C Cohort
n=3 Participants
All adverse events are grade 1-2.
|
|---|---|---|---|---|
|
Number of Patients With Disease Control at 8 Weeks
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: The time from the date of first edited T cell infusion to the date of disease progression or death due to any reason.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Pre-A Cohort
n=2 Participants
All adverse events are grade 1-2.
|
A Cohort
n=4 Participants
All adverse events are grade 1-2.
|
B Cohort
n=3 Participants
All adverse events are grade 1-2.
|
C Cohort
n=3 Participants
All adverse events are grade 1-2.
|
|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
11.7 weeks
Interval 5.6 to 17.7
|
8.0 weeks
Interval 7.3 to 8.4
|
8.1 weeks
Interval 7.4 to 75.7
|
6.1 weeks
Interval 5.0 to 8.1
|
SECONDARY outcome
Timeframe: The duration from date of first edited T cell infusion to the date of death due to any reasonOS is defined as the time interval from date of first edited T cell infusion to the date of death due to any reason
Outcome measures
| Measure |
Pre-A Cohort
n=2 Participants
All adverse events are grade 1-2.
|
A Cohort
n=4 Participants
All adverse events are grade 1-2.
|
B Cohort
n=3 Participants
All adverse events are grade 1-2.
|
C Cohort
n=3 Participants
All adverse events are grade 1-2.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
47.5 weeks
Interval 42.6 to 52.4
|
51.4 weeks
Interval 13.4 to 116.0
|
32.6 weeks
Interval 24.4 to 97.7
|
51.6 weeks
Interval 21.0 to 96.7
|
SECONDARY outcome
Timeframe: BaselinePopulation: Only three patients were detected with EGFR mutations. Correlation between driver gene mutations with clinical outcome were not analyzed due to limited data. EGFR positive rate was showed in outcome measure data table.
Driver genes mutaion stauts of Participants in ctDNA from peripheral blood were assessed by next generation sequencing (NGS), to explore the positive rate of sepicif driver genes (e.g. EGFR, ALK, ROS1, etc.) and the relationship between gene mutation status and clinical response
Outcome measures
| Measure |
Pre-A Cohort
n=2 Participants
All adverse events are grade 1-2.
|
A Cohort
n=4 Participants
All adverse events are grade 1-2.
|
B Cohort
n=3 Participants
All adverse events are grade 1-2.
|
C Cohort
n=3 Participants
All adverse events are grade 1-2.
|
|---|---|---|---|---|
|
Number of Participants With Genes Mutations in Peripheral Blood Circulating Tumor DNA (ctDNA)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1 month and 3 monthPopulation: One patients did not provide blood sample due to early withdrawal; blood samples of 8 patients were only collected at baseline and month 1 due to PD before month 3
Peripheral Interleukin-6 level at different timepoint (Baseline, 1 month and 3 month) was measured using rate nephelometry
Outcome measures
| Measure |
Pre-A Cohort
n=2 Participants
All adverse events are grade 1-2.
|
A Cohort
n=3 Participants
All adverse events are grade 1-2.
|
B Cohort
n=3 Participants
All adverse events are grade 1-2.
|
C Cohort
n=3 Participants
All adverse events are grade 1-2.
|
|---|---|---|---|---|
|
Interleukin-6 Change in the Peripheral Blood.
baseline
|
10.68 pg/ml
Interval 8.98 to 12.38
|
3.27 pg/ml
Interval 2.62 to 61.87
|
51.97 pg/ml
Interval 8.09 to 67.09
|
10.59 pg/ml
Interval 10.28 to 11.45
|
|
Interleukin-6 Change in the Peripheral Blood.
1 month
|
12.9 pg/ml
Interval 1.5 to 24.3
|
4.37 pg/ml
Interval 2.39 to 90.17
|
23.92 pg/ml
Interval 5.58 to 137.1
|
14.77 pg/ml
Interval 8.48 to 26.17
|
|
Interleukin-6 Change in the Peripheral Blood.
3 month
|
18.45 pg/ml
Interval 18.45 to 18.45
|
—
|
4.03 pg/ml
Interval 4.03 to 4.03
|
12.49 pg/ml
Interval 12.49 to 12.49
|
SECONDARY outcome
Timeframe: Baseline, 1 month and 3 monthPopulation: One patients did not provide blood sample due to early withdrawal; blood samples of 8 patients were only collected at baseline and month 1 due to PD before month 3
Peripheral Interleukin-10 level at different timepoint (Baseline, 1 month and 3 month) was measured using chemiluminescence.
Outcome measures
| Measure |
Pre-A Cohort
n=2 Participants
All adverse events are grade 1-2.
|
A Cohort
n=3 Participants
All adverse events are grade 1-2.
|
B Cohort
n=3 Participants
All adverse events are grade 1-2.
|
C Cohort
n=3 Participants
All adverse events are grade 1-2.
|
|---|---|---|---|---|
|
Interleukin-10 Change in the Peripheral Blood.
baseline
|
5.00 pg/ml
Interval 5.0 to 5.0
|
5.00 pg/ml
Interval 5.0 to 5.0
|
5.00 pg/ml
Interval 5.0 to 5.0
|
5.00 pg/ml
Interval 5.0 to 5.0
|
|
Interleukin-10 Change in the Peripheral Blood.
1 month
|
5.00 pg/ml
Interval 5.0 to 5.0
|
5.00 pg/ml
Interval 5.0 to 5.0
|
19.05 pg/ml
Interval 7.3 to 30.8
|
5.00 pg/ml
Interval 5.0 to 5.0
|
|
Interleukin-10 Change in the Peripheral Blood.
3 month
|
5.00 pg/ml
Interval 5.0 to 5.0
|
—
|
27.10 pg/ml
Interval 27.1 to 27.1
|
5.00 pg/ml
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline, 1 month and 3 monthPopulation: One patients did not provide blood sample due to early withdrawal; blood samples of 8 patients were only collected at baseline and month 1 due to PD before month 3
Peripheral Tumor Necrosis Factor-a level at different timepoint (Baseline, 1 month and 3 month) was measured using chemiluminescence.
Outcome measures
| Measure |
Pre-A Cohort
n=2 Participants
All adverse events are grade 1-2.
|
A Cohort
n=3 Participants
All adverse events are grade 1-2.
|
B Cohort
n=3 Participants
All adverse events are grade 1-2.
|
C Cohort
n=3 Participants
All adverse events are grade 1-2.
|
|---|---|---|---|---|
|
Tumor Necrosis Factor-a Change in the Peripheral Blood.
baseline
|
13.84 pg/ml
Interval 7.97 to 19.7
|
6.07 pg/ml
Interval 5.61 to 8.53
|
8.89 pg/ml
Interval 5.3 to 8.92
|
5.06 pg/ml
Interval 4.01 to 6.28
|
|
Tumor Necrosis Factor-a Change in the Peripheral Blood.
1 month
|
10.68 pg/ml
Interval 7.65 to 13.7
|
7.84 pg/ml
Interval 5.74 to 7.92
|
10.40 pg/ml
Interval 4.2 to 11.9
|
16.4 pg/ml
Interval 6.31 to 27.7
|
|
Tumor Necrosis Factor-a Change in the Peripheral Blood.
3 month
|
6.97 pg/ml
Interval 6.97 to 6.97
|
—
|
10.90 pg/ml
Interval 10.9 to 10.9
|
11.70 pg/ml
Interval 11.7 to 11.7
|
Adverse Events
Pre-A Cohort
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
A Cohort
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
B Cohort
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
C Cohort
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pre-A Cohort
n=2 participants at risk
Grade 1/2 treatment-related adverse events (AEs) occurred in 2 patients.
|
A Cohort
n=4 participants at risk
Grade 1/2 treatment-related adverse events (AEs) occurred in 4 patients.
|
B Cohort
n=3 participants at risk
Grade 1/2 treatment-related adverse events (AEs) occurred in 3 patients.
|
C Cohort
n=3 participants at risk
Grade 1/2 treatment-related adverse events (AEs) occurred in 2 patients.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/4 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
|
Immune system disorders
Arthralgia
|
0.00%
0/2 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/4 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
|
Cardiac disorders
Premature beats
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/4 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
|
Immune system disorders
Increased AST
|
0.00%
0/2 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/4 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
|
General disorders
Hypertension
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/4 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
|
Immune system disorders
Increased ALT
|
50.0%
1/2 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/4 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
|
General disorders
Fever
|
0.00%
0/2 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/4 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
66.7%
2/3 • Number of events 2 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
|
General disorders
Hyperhidrosis
|
0.00%
0/2 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/4 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
|
General disorders
Infusion-related reaction
|
0.00%
0/2 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
25.0%
1/4 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/4 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/4 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
33.3%
1/3 • Number of events 1 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
0.00%
0/3 • Adverse event data were collected for 2 years.
Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place