Trial Outcomes & Findings for Interleukin-15 Armored Glypican 3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors (NCT NCT04377932)
NCT ID: NCT04377932
Last Updated: 2026-01-21
Results Overview
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the GPC3-CAR T cells. Specifically those which are Grade 5; non-hematologic Grade 3-4 not returning to Grade 2 within 72 hours; Grade 2-4 allergic reaction; grade 4 hematologic toxicity that persists for 28 days or greater; all grade 4 CRS and neurologic toxicities and grade 3 CRS and neurologic toxicities that fail to return to Grade 1 within 7 days.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
4 weeks
Results posted on
2026-01-21
Participant Flow
Participant milestones
| Measure |
15.GPC3-CAR T Cells - Dose Level 1
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 1 (3x10\^7/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
15.GPC3-CAR T Cells - Dose Level 2
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 2 (DL2: 1x10\^8/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
15.GPC3-CAR T Cells - Dose Level 3
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 3 (DL3: 3x10\^8/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
|---|---|---|---|
|
Dose Level 1
STARTED
|
8
|
0
|
0
|
|
Dose Level 1
COMPLETED
|
0
|
0
|
0
|
|
Dose Level 1
NOT COMPLETED
|
8
|
0
|
0
|
|
Dose Level 2
STARTED
|
0
|
3
|
0
|
|
Dose Level 2
COMPLETED
|
0
|
0
|
0
|
|
Dose Level 2
NOT COMPLETED
|
0
|
3
|
0
|
|
Dose Level 3
STARTED
|
0
|
0
|
3
|
|
Dose Level 3
COMPLETED
|
0
|
0
|
0
|
|
Dose Level 3
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
15.GPC3-CAR T Cells - Dose Level 1
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 1 (3x10\^7/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
15.GPC3-CAR T Cells - Dose Level 2
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 2 (DL2: 1x10\^8/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
15.GPC3-CAR T Cells - Dose Level 3
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 3 (DL3: 3x10\^8/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
|---|---|---|---|
|
Dose Level 1
Death
|
7
|
0
|
0
|
|
Dose Level 1
On long term follow up
|
1
|
0
|
0
|
|
Dose Level 2
Death
|
0
|
3
|
0
|
|
Dose Level 3
Death
|
0
|
0
|
2
|
|
Dose Level 3
On long term follow up
|
0
|
0
|
1
|
Baseline Characteristics
Interleukin-15 Armored Glypican 3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors
Baseline characteristics by cohort
| Measure |
15.GPC3-CAR T Cells - Dose Level 1
n=8 Participants
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 1 (3x10\^7/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
15.GPC3-CAR T Cells - Dose Level 2
n=3 Participants
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 2 (DL2: 1x10\^8/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
15.GPC3-CAR T Cells - Dose Level 3
n=3 Participants
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 3 (DL3: 3x10\^8/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
10.5 years
n=37 Participants
|
4.0 years
n=44 Participants
|
11.0 years
n=40 Participants
|
10.5 years
n=121 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
2 Participants
n=40 Participants
|
6 Participants
n=121 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=37 Participants
|
3 Participants
n=44 Participants
|
1 Participants
n=40 Participants
|
8 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=37 Participants
|
3 Participants
n=44 Participants
|
3 Participants
n=40 Participants
|
14 Participants
n=121 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=37 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=121 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=37 Participants
|
2 Participants
n=44 Participants
|
2 Participants
n=40 Participants
|
10 Participants
n=121 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Analysis population included participants who received 15.GPC3-CAR T cells and were evaluable for dose limiting toxicity (DLT), defined as those who developed DLTs or completed the 4-week DLT evaluation period after the T cell infusion. One participant at dose level 3 did not complete the DLT evaluation and was not evaluable for DLT.
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the GPC3-CAR T cells. Specifically those which are Grade 5; non-hematologic Grade 3-4 not returning to Grade 2 within 72 hours; Grade 2-4 allergic reaction; grade 4 hematologic toxicity that persists for 28 days or greater; all grade 4 CRS and neurologic toxicities and grade 3 CRS and neurologic toxicities that fail to return to Grade 1 within 7 days.
Outcome measures
| Measure |
15.GPC3-CAR T Cells - Dose Level 1
n=8 Participants
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 1 (3x10\^7/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
15.GPC3-CAR T Cells - Dose Level 2
n=3 Participants
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 2 (DL2: 1x10\^8/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
15.GPC3-CAR T Cells - Dose Level 3
n=2 Participants
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 3 (DL3: 3x10\^8/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
|---|---|---|---|
|
Number of Patients With Dose Limiting Toxicity
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Analysis population included participants who received 15.GPC3-CAR T cells and had available response data . One participant at dose level 3 was excluded because response data were not available.
Response rate is calculated as the percentage of subjects with the best overall response that is either complete response or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Outcome measures
| Measure |
15.GPC3-CAR T Cells - Dose Level 1
n=8 Participants
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 1 (3x10\^7/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
15.GPC3-CAR T Cells - Dose Level 2
n=3 Participants
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 2 (DL2: 1x10\^8/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
15.GPC3-CAR T Cells - Dose Level 3
n=2 Participants
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 3 (DL3: 3x10\^8/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
|---|---|---|---|
|
Response Rate
|
50.0 Percentage of participants
Interval 15.7 to 84.3
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
50.0 Percentage of participants
Interval 1.3 to 98.7
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Analysis population included all participants who received 15.GPC3-CAR T cells and were evaluable for DLT, defined as those who developed DLTs or completed the 4-week DLT evaluation period after the T cell infusion. One participant at dose level 3 was excluded because the participant did not complete the DLT evaluation period and was not evaluable for DLT.
Defined as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. If there is no DLT that determine a MTD, the maximum dose level will be declared as the MTD. In case the lowest dose level is determined to be too toxic and the elimination boundary is reached, no MTD will be defined for the trial.
Outcome measures
| Measure |
15.GPC3-CAR T Cells - Dose Level 1
n=13 Participants
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 1 (3x10\^7/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
15.GPC3-CAR T Cells - Dose Level 2
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 2 (DL2: 1x10\^8/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
15.GPC3-CAR T Cells - Dose Level 3
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 3 (DL3: 3x10\^8/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Autologous Glypican-3 Specific Chimeric Antigen Expressing T Cells Co-expressing IL-15 Administered to Patients With GPC3-positive Solid Tumors.
|
3.0 10^8 cells per square meter
|
—
|
—
|
Adverse Events
15.GPC3-CAR T Cells - Dose Level 1
Serious events: 6 serious events
Other events: 8 other events
Deaths: 7 deaths
15.GPC3-CAR T Cells - Dose Level 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
15.GPC3-CAR T Cells - Dose Level 3
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
15.GPC3-CAR T Cells - Dose Level 1
n=8 participants at risk
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 1 (3x10\^7/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
15.GPC3-CAR T Cells - Dose Level 2
n=3 participants at risk
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 2 (DL2: 1x10\^8/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
15.GPC3-CAR T Cells - Dose Level 3
n=3 participants at risk
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 3 (DL3: 3x10\^8/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify : phonophobia
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Eye disorders
Photophobia
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
General disorders and administration site conditions
Fatigue
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
General disorders and administration site conditions
Fever
|
62.5%
5/8 • Number of events 8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 10 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
General disorders and administration site conditions
Flu like symptoms
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Immune system disorders
Cytokine release syndrome
|
62.5%
5/8 • Number of events 14 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Infections and infestations
Infections and infestations-Other,specify:Bacteremia due to e.coli. without vomiting or diarrhea
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Infections and infestations
Infections and infestations - Other, specify : budding yeast infection at vascular access port
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Investigations
White blood cell decreased
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Nervous system disorders
Nervous system disorders - Other, specify : Disease progression to the brain and nervous system
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Nervous system disorders
Nervous system disorders - Other, specify : cerebral hemorrhage
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Nervous system disorders
Nervous system disorders - Other, specify : neurologic failure
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Nervous system disorders
Stroke
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
Other adverse events
| Measure |
15.GPC3-CAR T Cells - Dose Level 1
n=8 participants at risk
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 1 (3x10\^7/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
15.GPC3-CAR T Cells - Dose Level 2
n=3 participants at risk
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 2 (DL2: 1x10\^8/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
15.GPC3-CAR T Cells - Dose Level 3
n=3 participants at risk
Participants with GPC3-positive solid tumors received an intravenous injection of 15.GPC3-CAR T cells at Dose Level 3 (DL3: 3x10\^8/m2) after lymphodepleting chemotherapy. The dose was calculated according to the actual number of GPC3-CAR transduced T cells.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
87.5%
7/8 • Number of events 10 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 4 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Cardiac disorders
Sinus tachycardia
|
37.5%
3/8 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Eye disorders
Eye pain
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Eye disorders
Photophobia
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
3/8 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
25.0%
2/8 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
6/8 • Number of events 10 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
100.0%
3/3 • Number of events 4 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
4/8 • Number of events 5 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
100.0%
3/3 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
General disorders and administration site conditions
Chills
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
General disorders and administration site conditions
Edema face
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
General disorders and administration site conditions
Edema limbs
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
General disorders and administration site conditions
Facial pain
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
General disorders and administration site conditions
Fatigue
|
37.5%
3/8 • Number of events 4 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 6 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
General disorders and administration site conditions
Fever
|
62.5%
5/8 • Number of events 9 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Immune system disorders
Cytokine release syndrome
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Infections and infestations
Thrush
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Investigations
Alanine aminotransferase increased
|
87.5%
7/8 • Number of events 8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
1/8 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
8/8 • Number of events 8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Investigations
Blood bilirubin increased
|
37.5%
3/8 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Investigations
Creatinine increased
|
62.5%
5/8 • Number of events 5 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Investigations
GGT increased
|
37.5%
3/8 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Investigations
INR increased
|
25.0%
2/8 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
8/8 • Number of events 11 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
100.0%
3/3 • Number of events 5 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
100.0%
3/3 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Investigations
Neutrophil count decreased
|
100.0%
8/8 • Number of events 11 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
100.0%
3/3 • Number of events 5 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
100.0%
3/3 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Investigations
Platelet count decreased
|
87.5%
7/8 • Number of events 10 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
100.0%
3/3 • Number of events 5 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Investigations
White blood cell decreased
|
100.0%
8/8 • Number of events 10 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
100.0%
3/3 • Number of events 5 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
100.0%
3/3 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
2/8 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
8/8 • Number of events 10 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
100.0%
3/3 • Number of events 4 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
87.5%
7/8 • Number of events 7 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
8/8 • Number of events 10 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
25.0%
2/8 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
75.0%
6/8 • Number of events 8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
75.0%
6/8 • Number of events 6 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
75.0%
6/8 • Number of events 8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 4 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
100.0%
3/3 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
66.7%
2/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Reproductive system and breast disorders
Genital edema
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.5%
3/8 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
25.0%
2/8 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify : mild chest pain upon inhalation
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
2/8 • Number of events 3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify : Genital Itchiness
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify : HSV+ ulcers in mouth
|
12.5%
1/8 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify : Periorbital Edema
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Vascular disorders
Flushing
|
0.00%
0/8 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
|
Vascular disorders
Hypotension
|
25.0%
2/8 • Number of events 2 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
0.00%
0/3 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
33.3%
1/3 • Number of events 1 • Data on adverse experiences/toxicities regardless of seriousness were collected for documentation purposes only for 4 weeks after the last dosing of the study drug/biologic.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place