Trial Outcomes & Findings for Study Investigating NTLA-5001 in Subjects With Acute Myeloid Leukemia (NCT NCT05066165)
NCT ID: NCT05066165
Last Updated: 2023-12-28
Results Overview
DLTs were defined as events with onset within 28 days of infusion. AEs were collected from time of informed consent through the Week 112 visit. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA) version 24.0. Severity of AEs was assessed by the investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 toxicity grading criteria. The measure reported below for the primary outcome consists of DLT data only. Adverse events are reported in the Adverse Event section of this presentation.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Primary DLT assessment from NTLA-5001 infusion up to 28 days post-infusion
Results posted on
2023-12-28
Participant Flow
A total of 6 participants were enrolled at 3 sites in one country. A total of 2 participants received the product at Dose Level 1 in the Dose Escalation phase. The first participant was enrolled on 17 December 2021 and the last participant was enrolled on 21 July 2022. Dose escalation phase did not proceed beyond Dose Level 1. Dose Expansion phase was not initiated.
Six participants were enrolled in the study (signed informed consent and underwent leukapheresis), but only two participants were dosed (administered Dose Level 1).
Participant milestones
| Measure |
Arm 1: NTLA-5001 Participants With AML Blasts < 5% of Bone Marrow
Arm 1: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
Arm 2: NTLA-5001 Participants With AML Blasts ≥ 5% of Bone Marrow
Arm 2: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
|---|---|---|
|
C1:DoseLevel1 Assignment
STARTED
|
1
|
5
|
|
C1:DoseLevel1 Assignment
COMPLETED
|
1
|
1
|
|
C1:DoseLevel1 Assignment
NOT COMPLETED
|
0
|
4
|
|
C1:DoseLevel1 Dosed Participants (W1-16)
STARTED
|
1
|
1
|
|
C1:DoseLevel1 Dosed Participants (W1-16)
COMPLETED
|
0
|
0
|
|
C1:DoseLevel1 Dosed Participants (W1-16)
NOT COMPLETED
|
1
|
1
|
|
Cohort2:Dose Level 2
STARTED
|
0
|
0
|
|
Cohort2:Dose Level 2
COMPLETED
|
0
|
0
|
|
Cohort2:Dose Level 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm 1: NTLA-5001 Participants With AML Blasts < 5% of Bone Marrow
Arm 1: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
Arm 2: NTLA-5001 Participants With AML Blasts ≥ 5% of Bone Marrow
Arm 2: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
|---|---|---|
|
C1:DoseLevel1 Assignment
Pivoting to an allogeneic version of this program
|
0
|
4
|
|
C1:DoseLevel1 Dosed Participants (W1-16)
Death
|
1
|
1
|
Baseline Characteristics
Study Investigating NTLA-5001 in Subjects With Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Arm 1: NTLA-5001 Participants With AML Blasts < 5% of Bone Marrow
n=1 Participants
Arm 1: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy.
|
Arm 2: NTLA-5001 Participants With AML Blasts ≥ 5% of Bone Marrow
n=5 Participants
Arm 2: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
57 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Body Mass Index
|
37.7 kg/m^2
STANDARD_DEVIATION 0 • n=5 Participants
|
24.3 kg/m^2
STANDARD_DEVIATION 6.63 • n=7 Participants
|
26.5 kg/m^2
STANDARD_DEVIATION 8.07 • n=5 Participants
|
|
Height
|
190.0 cm
STANDARD_DEVIATION 0 • n=5 Participants
|
170.2 cm
STANDARD_DEVIATION 9.18 • n=7 Participants
|
173.5 cm
STANDARD_DEVIATION 11.52 • n=5 Participants
|
|
Weight
|
136.0 kg
STANDARD_DEVIATION 0 • n=5 Participants
|
71.3 kg
STANDARD_DEVIATION 24.79 • n=7 Participants
|
82.1 kg
STANDARD_DEVIATION 34.50 • n=5 Participants
|
PRIMARY outcome
Timeframe: Primary DLT assessment from NTLA-5001 infusion up to 28 days post-infusionPopulation: The Safety Analysis Set (defined as all participants who received NTLA-5001) was used for this presentation.
DLTs were defined as events with onset within 28 days of infusion. AEs were collected from time of informed consent through the Week 112 visit. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA) version 24.0. Severity of AEs was assessed by the investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 toxicity grading criteria. The measure reported below for the primary outcome consists of DLT data only. Adverse events are reported in the Adverse Event section of this presentation.
Outcome measures
| Measure |
Arm 1: NTLA-5001 Participants With AML Blasts < 5% of Bone Marrow
n=1 Participants
Arm 1: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
Arm 2: NTLA-5001 Participants With AML Blasts ≥ 5% of Bone Marrow
n=1 Participants
Arm 2: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
|---|---|---|
|
Participants That Experienced Dose-limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From NTLA-5001 infusion up to 4 weeks post-infusionPopulation: The Cell Kinetics Analysis Set (defined as all participants who received NTLA-5001 and have at least one evaluable cell kinetics sample) was used for this presentation.
Frequency of edited TCR transgene copy number in the peripheral blood of the participants was determined by droplet digital polymerase chain reaction (ddPCR).
Outcome measures
| Measure |
Arm 1: NTLA-5001 Participants With AML Blasts < 5% of Bone Marrow
n=1 Participants
Arm 1: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
Arm 2: NTLA-5001 Participants With AML Blasts ≥ 5% of Bone Marrow
n=1 Participants
Arm 2: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
|---|---|---|
|
Frequency of NTLA-5001 T-cell Receptor (TCR) Transgene Copy Number in the Peripheral Blood
|
NA copy/ng gDNA
Standard Deviation NA
Transgene in all collected patients' samples were below limit of quantification or negative
|
NA copy/ng gDNA
Standard Deviation NA
Transgene in all collected patients' samples were below limit of quantification or negative
|
SECONDARY outcome
Timeframe: From NTLA-5001 infusion up to 4 weeks post-infusionPopulation: The Cell Kinetics Analysis Set (defined as all participants who received NTLA-5001 and have at least one evaluable cell kinetics sample) was used for this presentation.
Persistence of edited TCR transgene copy in the peripheral blood of the participants determined by ddPCR.
Outcome measures
| Measure |
Arm 1: NTLA-5001 Participants With AML Blasts < 5% of Bone Marrow
n=1 Participants
Arm 1: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
Arm 2: NTLA-5001 Participants With AML Blasts ≥ 5% of Bone Marrow
n=1 Participants
Arm 2: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
|---|---|---|
|
Persistence of NTLA-5001 T Cell Receptor (TCR) Transgene Copy in Peripheral Blood
|
NA Days
Transgene levels and Persistence were not quantifiable, as no participant had measurable values for edited TCR transgene copies
|
NA Days
Transgene levels and Persistence were not quantifiable, as no participant had measurable values for edited TCR transgene copies
|
SECONDARY outcome
Timeframe: From NTLA-5001 infusion up to 4 weeks post-infusionPopulation: The Safety Analysis Set (defined as all participants who received NTLA-5001) was used for presentations of disease response data.
Rate of objective response, where response is complete response without measurable residual disease (CRMRD-) (Arm 1). Rate of objective response, where response is CRMRD-, complete response, complete remission with incomplete hematologic recovery, morphologic leukemia-free state, and partial remission (Arm 2).
Outcome measures
| Measure |
Arm 1: NTLA-5001 Participants With AML Blasts < 5% of Bone Marrow
n=1 Participants
Arm 1: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
Arm 2: NTLA-5001 Participants With AML Blasts ≥ 5% of Bone Marrow
n=1 Participants
Arm 2: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
|---|---|---|
|
Tumor Response in Participants With AML
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From NTLA-5001 infusion up to 4 weeks post-infusionPopulation: The Safety Analysis Set (defined as all participants who received NTLA-5001) was used for presentations of disease response data.
Bone marrow results were planned to be used to determine the duration of response / remission (DOR) for subjects with objective response, from first response until MRD was measured above the lower level of detection for the central laboratory assay, or death from any cause, whichever occurred first (Arm 1). Bone marrow results were planned to be used to determine DOR for subjects with composite CR, from first response to progression or death due to any cause, whichever occurred first (Arm 2).
Outcome measures
| Measure |
Arm 1: NTLA-5001 Participants With AML Blasts < 5% of Bone Marrow
n=1 Participants
Arm 1: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
Arm 2: NTLA-5001 Participants With AML Blasts ≥ 5% of Bone Marrow
n=1 Participants
Arm 2: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
|---|---|---|
|
Response Duration in Participants With AML
|
NA Weeks
Standard Deviation NA
Both participants experienced disease progression at the first assessment
|
NA Weeks
Standard Deviation NA
Both participants experienced disease progression at the first assessment
|
SECONDARY outcome
Timeframe: From NTLA-5001 infusion up to 4 weeks post-infusionPopulation: The Safety Analysis Set (defined as all participants who received NTLA-5001) was used for presentations of disease response data.
Bone marrow results were used to determine the time to clinical progression. Progressive disease was defined as an increase from baseline of at least 25% of bone marrow blasts or an absolute increase of at least 5,000 cells/μL in the number of circulating leukemia cells
Outcome measures
| Measure |
Arm 1: NTLA-5001 Participants With AML Blasts < 5% of Bone Marrow
n=1 Participants
Arm 1: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
Arm 2: NTLA-5001 Participants With AML Blasts ≥ 5% of Bone Marrow
n=1 Participants
Arm 2: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
|---|---|---|
|
Disease Progression in Participants With AML
|
NA Weeks
Standard Deviation NA
Both participants experienced disease progression at the first assessment
|
NA Weeks
Standard Deviation NA
Both participants experienced disease progression at the first assessment
|
Adverse Events
Arm 1: NTLA-5001 Participants With AML Blasts < 5% of Bone Marrow
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Arm 2: NTLA-5001 Participants With AML Blasts ≥ 5% of Bone Marrow
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm 1: NTLA-5001 Participants With AML Blasts < 5% of Bone Marrow
n=1 participants at risk
Arm 1: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
Arm 2: NTLA-5001 Participants With AML Blasts ≥ 5% of Bone Marrow
n=1 participants at risk
Arm 2: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
Other adverse events
| Measure |
Arm 1: NTLA-5001 Participants With AML Blasts < 5% of Bone Marrow
n=1 participants at risk
Arm 1: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
Arm 2: NTLA-5001 Participants With AML Blasts ≥ 5% of Bone Marrow
n=1 participants at risk
Arm 2: NTLA-5001: Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. The participant was administered Dose Level 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
General disorders
Fatigue
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
General disorders
Chills
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Injury, poisoning and procedural complications
Contusion
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Psychiatric disorders
Hallucination
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Psychiatric disorders
Affect lability
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Psychiatric disorders
Abnormal dreams
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Renal and urinary disorders
Haematuria
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
|
Vascular disorders
Hypertension
|
100.0%
1/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
0.00%
0/1 • From the date of NTLA-5001 infusion up to 16 weeks post-infusion.
Safety population = all participants who received NTLA-5001.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place