Trial Outcomes & Findings for Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy (NCT NCT05075603)
NCT ID: NCT05075603
Last Updated: 2026-08-10
Results Overview
Treatment-Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) with an onset date on or after NT-I7 administration and on or before Day 100. A serious TEAE is defined as any AE that resulted in any of the following outcomes: death; a life-threatening AE; an AE that resulted in inpatient hospitalization or prolongation of existing hospitalization for ≥24 hours; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect; important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
From NT-I7 administration (Day 21) to Day 100
Results posted on
2026-08-10
Participant Flow
A total of 17 participants were enrolled in the United States from July 2021 to March 2025.
The trial consisted of a dose-escalation phase (Phase 1b). Participants received NT-I7 as an intramuscular (IM) injection on Day 21 across seven dose levels ranging from 60 µg/kg to 720 µg/kg. Participants received CAR-T therapy (Kymriah®, Yescarta®, or Breyanzi®) as an intravenous (IV) infusion on Day 0. Dose expansion phase did not occur.
Participant milestones
| Measure |
Dose Level 1: 60 µg/kg
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 2: 120 µg/kg
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 3: 240 µg/kg
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 4: 360 µg/kg
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 5: 480 µg/kg
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 6: 600 µg/kg
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 7: 720 µg/kg
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
Received CAR T-Cell Therapy Treatment
|
1
|
1
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
Received Kymriah®
|
1
|
1
|
3
|
3
|
1
|
0
|
0
|
|
Overall Study
Received Yescarta®
|
0
|
0
|
0
|
0
|
1
|
2
|
2
|
|
Overall Study
Received Breyanzi®
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Completed Dose-Limiting Toxicity (DLT) Review Period
|
1
|
1
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
Completed Follow-up
|
1
|
0
|
1
|
0
|
2
|
3
|
3
|
|
Overall Study
Discontinuation from Follow-up
|
0
|
1
|
2
|
3
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
2
|
2
|
1
|
0
|
0
|
|
Overall Study
Withdrawal of Consent
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
|
1
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Relapsed/Refractory Large B-cell Lymphoma With NT-I7 Post-CD19 CAR T-cell Therapy
Baseline characteristics by cohort
| Measure |
Dose Level 1: 60 µg/kg
n=1 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 2: 120 µg/kg
n=1 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 3: 240 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 4: 360 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 5: 480 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 6: 600 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 7: 720 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64 years
n=54 Participants
|
74 years
n=54 Participants
|
69 years
n=27 Participants
|
63 years
n=26 Participants
|
63 years
n=161 Participants
|
68 years
n=120 Participants
|
50 years
n=18 Participants
|
64 years
n=92 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
1 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
4 Participants
n=92 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=26 Participants
|
3 Participants
n=161 Participants
|
2 Participants
n=120 Participants
|
3 Participants
n=18 Participants
|
13 Participants
n=92 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=92 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
1 Participants
n=18 Participants
|
3 Participants
n=92 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=92 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=92 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=26 Participants
|
2 Participants
n=161 Participants
|
3 Participants
n=120 Participants
|
2 Participants
n=18 Participants
|
13 Participants
n=92 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=92 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=92 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=92 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=54 Participants
|
1 Participants
n=54 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=26 Participants
|
2 Participants
n=161 Participants
|
3 Participants
n=120 Participants
|
3 Participants
n=18 Participants
|
16 Participants
n=92 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=161 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=92 Participants
|
|
Weight (kg)
|
73.6 kilogram (kg)
n=54 Participants
|
67.2 kilogram (kg)
n=54 Participants
|
67.4 kilogram (kg)
n=27 Participants
|
92.5 kilogram (kg)
n=26 Participants
|
91.3 kilogram (kg)
n=161 Participants
|
86.6 kilogram (kg)
n=120 Participants
|
80.6 kilogram (kg)
n=18 Participants
|
81.6 kilogram (kg)
n=92 Participants
|
PRIMARY outcome
Timeframe: From NT-I7 administration (Day 21) to Day 100Population: Safety Population: All participants who received NT-I7 administration.
Treatment-Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) with an onset date on or after NT-I7 administration and on or before Day 100. A serious TEAE is defined as any AE that resulted in any of the following outcomes: death; a life-threatening AE; an AE that resulted in inpatient hospitalization or prolongation of existing hospitalization for ≥24 hours; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect; important medical events that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Outcome measures
| Measure |
Dose Level 5: 480 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 6: 600 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 7: 720 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 1: 60 µg/kg
n=1 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 2: 120 µg/kg
n=1 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 3: 240 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 4: 360 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines
Any TEAEs
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines
TEAEs with Grade 3 or higher
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines
TEAEs Related to NT-I7
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines
NT-I7 Related TEAEs with Grade 3 or higher
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines
TEAEs Related to CAR-T
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines
CAR-T Related TEAEs with Grade 3 or higher
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines
Any TEAEs Leading to Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines
Any Serious TEAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines
Any Serious TEAEs with Grade 3 or Higher
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines
Serious TEAEs Related to NT-I7
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines
Serious TEAEs Related to CAR-T
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines
TEAEs of CRS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence, Nature, and Severity of Adverse Events, Graded According to NCI CTCAE v5.0, Except for Cytokine Release Syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), Which Were Graded Based on ASTCT Guidelines
TEAEs of ICANS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From NT-I7 administration (Day 21) to Day 42Population: DLT Population: all participants in the safety population who completed the full 3-week DLT period or who did not complete the full 3-week DLT period due to the occurrence of a DLT.
A Dose-Limiting Toxicity (DLT) is defined as any TEAE occurring within the first 21 days after NT-I7 administration that is considered to be at least possibly, probably, or definitely related to NT-I7 per the investigator, and that meets at least one of the protocol-defined non-hematologic or hematologic criteria.
Outcome measures
| Measure |
Dose Level 5: 480 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 6: 600 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 7: 720 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 1: 60 µg/kg
n=1 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 2: 120 µg/kg
n=1 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 3: 240 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 4: 360 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Incidence and Nature of DLTs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Safety Population as all participants who received NT-I7 administration, and Per Protocol Population as all participants in the efficacy evaluable population who did not have any major protocol deviation. Per IWG response criteria for lymphoma (Lugano classification): Complete Response (CR), Score 1, 2, or 3 with or without a residual mass on 5PS; Partial Response (PR), Score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size.
The Recommended Phase 2 Dose (RP2D) was determined based on cumulative safety data and efficacy parameters (Objective Response Rate \[ORR\] and response rate at 6 months).
Outcome measures
| Measure |
Dose Level 5: 480 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 6: 600 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 7: 720 µg/kg
n=2 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 1: 60 µg/kg
n=1 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 2: 120 µg/kg
n=1 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 3: 240 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 4: 360 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Potential Correlation of Dose Levels With Safety and Efficacy Parameters
Response Rate at 6 Months
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Potential Correlation of Dose Levels With Safety and Efficacy Parameters
Overall Response Rate
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Per Protocol Population: All participants in the efficacy evaluable population who did not have any major protocol deviation. This population was used for the analysis of efficacy parameters.
Duration of Response (DoR) for the responders is defined as the time from the first occurrence of a documented objective response (Partial Response \[PR\] or Complete Response \[CR\]) to the time of the first documented disease progression or death from any cause, whichever occurs first, per the Lugano classification as determined by the investigator. Only participants with a response were assessed. The median DoR was estimated using a Kaplan-Meier method.
Outcome measures
| Measure |
Dose Level 5: 480 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 6: 600 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 7: 720 µg/kg
n=2 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 1: 60 µg/kg
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 2: 120 µg/kg
n=1 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 3: 240 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 4: 360 µg/kg
n=2 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Measurement of Duration of Response (DoR)
|
NA months
Interval 2.63 to
The median and upper bound of 95% confidence interval were not reached due to a high censoring rate.
|
NA months
The median and 95% confidence interval were not reached due to a high censoring rate.
|
NA months
The median and 95% confidence interval were not reached due to a high censoring rate.
|
—
|
2.01 months
Interval 2.01 to 2.01
|
2.11 months
Interval 2.01 to 22.86
|
1.84 months
Interval 1.84 to 1.91
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Per Protocol Population: all participants in the efficacy evaluable population who did not have any major protocol deviation. This population was used for the analysis of efficacy parameters.
Progression-Free Survival (PFS) is defined as the time from CAR T-cell administration to the first occurrence of disease progression or death from any cause, whichever occurs first. The Median PFS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Dose Level 5: 480 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 6: 600 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 7: 720 µg/kg
n=2 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 1: 60 µg/kg
n=1 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 2: 120 µg/kg
n=1 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 3: 240 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 4: 360 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Measurement of Progression-Free Survival (PFS)
|
NA months
Interval 3.52 to
The median and upper bound of 95% confidence interval were not reached due to a high censoring rate.
|
NA months
The median and 95% confidence interval were not reached due to a high censoring rate.
|
NA months
The median and 95% confidence interval were not reached due to a high censoring rate.
|
0.72 months
Interval 0.72 to 0.72
|
3.03 months
Interval 3.03 to 3.03
|
3.06 months
Interval 2.99 to 23.85
|
2.60 months
Interval 1.02 to 2.89
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Per Protocol Population: all participants in the efficacy evaluable population who did not have any major protocol deviation. This population was used for the analysis of efficacy parameters.
Overall Survival (OS) is defined as the time from CAR T-cell administration to death from any cause. The median OS was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Dose Level 5: 480 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 6: 600 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 7: 720 µg/kg
n=2 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 1: 60 µg/kg
n=1 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 2: 120 µg/kg
n=1 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 3: 240 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 4: 360 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Measurement of Overall Survival (OS)
|
NA months
Interval 6.71 to
The median and upper bound of 95% confidence interval were not reached due to a high censoring rate.
|
NA months
The median and 95% confidence interval were not reached due to a high censoring rate.
|
NA months
The median and 95% confidence interval were not reached due to a high censoring rate.
|
NA months
The median and 95% confidence interval were not reached due to a high censoring rate.
|
12.70 months
Interval 12.7 to 12.7
|
11.18 months
Interval 9.74 to 36.51
|
8.68 months
Interval 6.84 to 15.59
|
SECONDARY outcome
Timeframe: From NT-I7 administration (Day 21) to Day 100Population: Safety Population: All participants who received NT-I7 administration.
The Grades of Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) are assessed based on the American Society for Transplantation and Cellular Therapy (ASTCT).
Outcome measures
| Measure |
Dose Level 5: 480 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 6: 600 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 7: 720 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 1: 60 µg/kg
n=1 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 2: 120 µg/kg
n=1 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 3: 240 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 4: 360 µg/kg
n=3 Participants
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Rates of Grade 3 and Higher Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Treatment Emergent Adverse Events (TEAEs) of CRS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rates of Grade 3 and Higher Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
TEAEs of ICANS
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Dose Level 2: 120 µg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Dose Level 3: 240 µg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Dose Level 4: 360 µg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Dose Level 5: 480 µg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Dose Level 6: 600 µg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 7: 720 µg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 1: 60 µg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 2: 120 µg/kg
n=1 participants at risk
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 3: 240 µg/kg
n=3 participants at risk
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 4: 360 µg/kg
n=3 participants at risk
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 5: 480 µg/kg
n=3 participants at risk
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 6: 600 µg/kg
n=3 participants at risk
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 7: 720 µg/kg
n=3 participants at risk
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 1: 60 µg/kg
n=1 participants at risk
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
Other adverse events
| Measure |
Dose Level 2: 120 µg/kg
n=1 participants at risk
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 3: 240 µg/kg
n=3 participants at risk
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 4: 360 µg/kg
n=3 participants at risk
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 5: 480 µg/kg
n=3 participants at risk
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 6: 600 µg/kg
n=3 participants at risk
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 7: 720 µg/kg
n=3 participants at risk
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
Dose Level 1: 60 µg/kg
n=1 participants at risk
Participants received NT-I7 as an IM injection on Day 21. Participants received CAR-T therapy as an IV infusion on Day 0.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
1/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
100.0%
1/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
General disorders
Fatigue
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
66.7%
2/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
General disorders
Injection site erythema
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
General disorders
Injection site swelling
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
100.0%
1/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
General disorders
Influenza like illness
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
General disorders
Injection site pain
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
General disorders
Injection site pruritus
|
100.0%
1/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
General disorders
Localised oedema
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
66.7%
2/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
100.0%
1/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Vascular disorders
Embolism
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
33.3%
1/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/3 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
|
0.00%
0/1 • All-cause mortality was assessed up to 24 months. Serious and non-serious AEs were collected from the first administration of NT-I7 (Day 21) through Day 100.
TEAE is defined as an AE with onset date on or after NT-I7 administration and within Day 100. TEAEs are coded using MedDRA v24.0 and displayed in tables using System Organ Class (SOC) and Preferred Term (PT). Severity was assessed using the NCI-CTCAE v5.0, except for grading of CRS and ICANS, which were assessed based on ASTCT. A participant is counted only once, even if they had multiple AEs within a preferred term (PT).
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Additional Information
Gloria Bae, Clinical Project Coordinator
NeoImmuneTech, Inc
Phone: 2407207822
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place