Trial Outcomes & Findings for Phase III B in Acute Lymphoblastic Leukemia (NCT NCT03123939)
NCT ID: NCT03123939
Last Updated: 2021-07-21
Results Overview
Treatment emergent adverse events were collected from CTL019 infusion until end of study, up to 12 months
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
69 participants
Primary outcome timeframe
From CTL019 infusion until end of study, up to 12 months
Results posted on
2021-07-21
Participant Flow
Participants were enrolled in 11 study centers across 9 countries (Austria, Belgium, Canada, Germany, Spain, France, Italy, Japan, Norway).
This was a single arm study.
Participant milestones
| Measure |
CTL019
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Overall Study
STARTED
|
74
|
|
Overall Study
CTL019 Infused
|
69
|
|
Overall Study
Full Analysis Set (FAS)
|
69
|
|
Overall Study
Cellular Kinetic Analysis Set (CKAS)
|
69
|
|
Overall Study
Safety Set (SAF)
|
69
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
CTL019
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Overall Study
Lack of Efficacy
|
6
|
|
Overall Study
Death
|
5
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Subject/guardian decision
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
New therapy for study indication
|
1
|
|
Overall Study
Protocol deviation
|
1
|
|
Overall Study
Progressive disease
|
18
|
|
Overall Study
Discontinued prior to CTL019 infusion due to death
|
4
|
|
Overall Study
Discontinued prior to CTL019 infusion due to technical problems
|
1
|
Baseline Characteristics
Phase III B in Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
CTL019
n=69 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Age, Continuous
|
11.3 years
STANDARD_DEVIATION 6.72 • n=113 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=113 Participants
|
|
Race/Ethnicity, Customized
White
|
52 Participants
n=113 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=113 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=113 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=113 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=113 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=113 Participants
|
PRIMARY outcome
Timeframe: From CTL019 infusion until end of study, up to 12 monthsPopulation: The Safety Set (SAF) comprised of all the participants who received an infusion of CTL019
Treatment emergent adverse events were collected from CTL019 infusion until end of study, up to 12 months
Outcome measures
| Measure |
CTL019
n=69 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
69 Participants
|
SECONDARY outcome
Timeframe: From CTL019 infusion until Month 6Population: Full Analysis Set (FAS) comprised of all the participants who received an infusion of CTL019
ORR is defined as the proportion of participants with a best overall disease response of Complete remission (CR) or CR with incomplete blood count recovery (CRi), where the best overall disease response is defined as the best disease response recorded from CTL019 infusion until Month 6.
Outcome measures
| Measure |
CTL019
n=69 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Overall Remission Rate (ORR)
|
57 Participants
|
SECONDARY outcome
Timeframe: Month 6Population: Full Analysis Set (FAS) comprised of all the participants who received an infusion of CTL019
Proportion of participants who achieved CR or CRi at Month 6 without stem cell transplantation between CTL019 infusion and Month 6 response assessment
Outcome measures
| Measure |
CTL019
n=69 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Number of Participants Who Achieved CR or CRi at Month 6 Without Stem Cell Transplantation (SCT)
|
41 Participants
|
SECONDARY outcome
Timeframe: From CTL019 infusion until Month 6Population: Full Analysis Set (FAS) comprised of all the participants who received an infusion of CTL019
Proportion of participants who achieved CR or CRi and then proceeded to stem cell transplantation while in remission prior to Month 6 response assessment.
Outcome measures
| Measure |
CTL019
n=69 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Number of Participants Who Achieved CR or CRi and Then Proceeded to Stem Cell Transplantation (SCT) While in Remission Before Month 6 Assessment
|
1 Participants
|
SECONDARY outcome
Timeframe: Actual reported Time Frame: up to 14.4 months post CTL019 infusion (planned follow-up period per protocol was only 12 months post CTL019 infusion)Population: Full Analysis Set (FAS) comprised of all the participants who received an infusion of CTL019 and had a best overall response of CR or CRi
DOR is the duration of remission from the date when the response criteria of CR or CRi was first met post CTL019 infusion to the date of relapse or death due to acute lymphoblastic leukemia (ALL), whichever occured first.
Outcome measures
| Measure |
CTL019
n=57 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Duration of Response (DOR)
|
8.9 Months
Interval 1.7 to 14.4
|
SECONDARY outcome
Timeframe: Actual reported Time Frame: up to 14.4 months post CTL019 infusion (planned follow-up period per protocol was only 12 months post CTL019 infusion)Population: Full Analysis Set (FAS) comprised of all the participants who received an infusion of CTL019 and had a best overall response of CR or CRi
RFS is measured by the time from achievement of CR or CRi whichever occured first post CTL019 infusion, to relapse or death due to any cause during CR or CRi.
Outcome measures
| Measure |
CTL019
n=57 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Relapse-free Survival (RFS)
|
8.9 Months
Interval 1.7 to 14.4
|
SECONDARY outcome
Timeframe: Actual reported Time Frame: up to 15.1 months post CTL019 infusion (planned follow-up period per protocol was only 12 months post CTL019 infusion)Population: Full Analysis Set (FAS) comprised of all the participants who received an infusion of CTL019
EFS is the time from date of CTL019 infusion to the earliest of death, relapse or treatment failure.
Outcome measures
| Measure |
CTL019
n=69 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Event-free Survival (EFS)
|
8.97 Months
Interval 0.0 to 15.1
|
SECONDARY outcome
Timeframe: Actual reported Time Frame: up to 24.4 months post CTL019 infusion (planned follow-up period per protocol was only 12 months post CTL019 infusion)Population: Full Analysis Set (FAS) comprised of all the participants who received an infusion of CTL019
OS is the time from date of CTL019 infusion to the date of death due to any reason
Outcome measures
| Measure |
CTL019
n=69 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Overall Survival (OS)
|
11.7 Months
Interval 0.3 to 24.4
|
SECONDARY outcome
Timeframe: Day 28Population: Full Analysis Set (FAS) comprised of all the participants who received an infusion of CTL019
Proportion of participants who attained CR or CRi at Day 28 post CTL019 infusion.
Outcome measures
| Measure |
CTL019
n=69 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Number of Participants Who Attained CR or CRi at Day 28
|
59 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Full Analysis Set (FAS) comprised of all the participants who received an infusion of CTL019 and had a baseline bone marrow tumor burden result
Proportion of participants who attained CR or CRi at Day 28 post CTL019 infusion by baseline bone marrow tumor burden.
Outcome measures
| Measure |
CTL019
n=66 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Number of Participants Who Attained CR or CRi at Day 28 by Baseline Bone Marrow Tumor Burden
Low tumor burden (morphologic result < 50%)
|
26 Participants
|
|
Number of Participants Who Attained CR or CRi at Day 28 by Baseline Bone Marrow Tumor Burden
High tumor burden (morphologic result ≥ 50%)
|
40 Participants
|
SECONDARY outcome
Timeframe: Enrollment/Pre-chemotherapy and Day 28Population: Full Analysis Set (FAS) comprised of all the participants who received an infusion of CTL019
MRD in ALL refers to the presence of leukemic cells below the threshold of detection using conventional morphologic methods. The most frequently used methods for MRD assessment include multicolor flow cytometry to detect abnormal immunophenotypes and polymerase chain reaction (PCR) assays to detect clonal rearrangements in immunoglobulin heavy chain genes and/or T-cell receptor genes or fusion transcripts (e.g. BCR-ABL (Philadelphia chromosome)). The results include the descriptive summary of MRD qualitative result (positive/negative) before treatment and at Day 28 after treatment and before HSCT by local assessment (flow cytometry).
Outcome measures
| Measure |
CTL019
n=69 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Bone Marrow Minimum Residual Disease (MRD) Status by Flow Cytometry on Day 28 Post CTL019 Infusion
Enrollment/Pre-Chemotherapy · Negative
|
0 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by Flow Cytometry on Day 28 Post CTL019 Infusion
Enrollment/Pre-Chemotherapy · Positive
|
51 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by Flow Cytometry on Day 28 Post CTL019 Infusion
Enrollment/Pre-Chemotherapy · Unknown
|
4 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by Flow Cytometry on Day 28 Post CTL019 Infusion
Enrollment/Pre-Chemotherapy · Not done
|
1 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by Flow Cytometry on Day 28 Post CTL019 Infusion
Enrollment/Pre-Chemotherapy · Missing
|
13 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by Flow Cytometry on Day 28 Post CTL019 Infusion
Day 28 · Negative
|
44 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by Flow Cytometry on Day 28 Post CTL019 Infusion
Day 28 · Positive
|
4 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by Flow Cytometry on Day 28 Post CTL019 Infusion
Day 28 · Unknown
|
2 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by Flow Cytometry on Day 28 Post CTL019 Infusion
Day 28 · Not done
|
0 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by Flow Cytometry on Day 28 Post CTL019 Infusion
Day 28 · Missing
|
19 Participants
|
SECONDARY outcome
Timeframe: Enrollment/Pre-chemotherapy and Day 28Population: Full Analysis Set (FAS) comprised of all the participants who received an infusion of CTL019
MRD in ALL refers to the presence of leukemic cells below the threshold of detection using conventional morphologic methods. The most frequently used methods for MRD assessment include multicolor flow cytometry to detect abnormal immunophenotypes and polymerase chain reaction (PCR) assays to detect clonal rearrangements in immunoglobulin heavy chain genes and/or T-cell receptor genes or fusion transcripts (e.g. BCR-ABL (Philadelphia chromosome)). The results include the descriptive summary of MRD qualitative result (positive/negative) before treatment and at Day 28 after treatment and before HSCT by local assessment (qPCR).
Outcome measures
| Measure |
CTL019
n=69 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Bone Marrow Minimum Residual Disease (MRD) Status by qPCR on Day 28 Post CTL019 Infusion
Enrollment/Pre-Chemotherapy · Negative
|
1 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by qPCR on Day 28 Post CTL019 Infusion
Day 28 · Not done
|
0 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by qPCR on Day 28 Post CTL019 Infusion
Day 28 · Missing
|
35 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by qPCR on Day 28 Post CTL019 Infusion
Enrollment/Pre-Chemotherapy · Positive
|
32 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by qPCR on Day 28 Post CTL019 Infusion
Enrollment/Pre-Chemotherapy · Unknown
|
4 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by qPCR on Day 28 Post CTL019 Infusion
Enrollment/Pre-Chemotherapy · Not done
|
0 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by qPCR on Day 28 Post CTL019 Infusion
Enrollment/Pre-Chemotherapy · Missing
|
32 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by qPCR on Day 28 Post CTL019 Infusion
Day 28 · Negative
|
31 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by qPCR on Day 28 Post CTL019 Infusion
Day 28 · Positive
|
3 Participants
|
|
Bone Marrow Minimum Residual Disease (MRD) Status by qPCR on Day 28 Post CTL019 Infusion
Day 28 · Unknown
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 14, Day 28, Month 3, Month 6 and Month 12Population: The Safety Set (SAF) comprised of all the participants who received an infusion of CTL019
The humoral immunogenicity assessment included evaluation of pre-existing (pre-treatment) and post-treatment anti-CTL019 antibodies to examine the incidence of immunogenicity with treatment.
Outcome measures
| Measure |
CTL019
n=69 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Month 3 · Negative
|
5 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Month 3 · Missing
|
11 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Month 6 · Positive
|
44 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Baseline · Positive
|
62 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Baseline · Negative
|
7 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Baseline · Missing
|
0 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Day 14 · Positive
|
53 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Day 14 · Negative
|
14 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Day 14 · Missing
|
2 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Day 28 · Positive
|
50 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Day 28 · Negative
|
13 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Day 28 · Missing
|
6 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Month 3 · Positive
|
53 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Month 6 · Negative
|
4 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Month 6 · Missing
|
21 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Month 12 · Positive
|
32 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Month 12 · Negative
|
1 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Humoral Immunogenicity
Month 12 · Missing
|
36 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 14, Day 28, Month 3, Month 6 and Month 12Population: The Safety Set (SAF) comprised of all the participants who received an infusion of CTL019
The cellular immunogenicity assessment included percentage of CD4+ and CD8+ T- cells specific for CTL019.
Outcome measures
| Measure |
CTL019
n=69 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 1 CD3+ CD4+ IFNg+ Baseline
|
69 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 1 CD3+ CD4+ IFNg+ Day 14
|
65 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 1 CD3+ CD4+ IFNg+ Day 28
|
63 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 1 CD3+ CD4+ IFNg+ Month 3
|
58 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 1 CD3+ CD4+ IFNg+ Month 6
|
51 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 1 CD3+ CD4+ IFNg+ Month 12
|
34 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 2 CD3+ CD4+ IFNg+ Baseline
|
69 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 2 CD3+ CD4+ IFNg+ Day 14
|
65 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 2 CD3+ CD4+ IFNg+ Day 28
|
63 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 2 CD3+ CD4+ IFNg+ Month 3
|
58 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 2 CD3+ CD4+ IFNg+ Month 6
|
51 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 2 CD3+ CD4+ IFNg+ Month 12
|
34 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 1 CD3+ CD8+ IFNg+ Baseline
|
69 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 1 CD3+ CD8+ IFNg+ Day 14
|
65 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 1 CD3+ CD8+ IFNg+ Day 28
|
63 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 1 CD3+ CD8+ IFNg+ Month 3
|
58 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 1 CD3+ CD8+ IFNg+ Month 6
|
51 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 1 CD3+ CD8+ IFNg+ Month 12
|
34 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 2 CD3+ CD8+ IFNg+ Baseline
|
69 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 2 CD3+ CD8+ IFNg+ Day 14
|
65 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 2 CD3+ CD8+ IFNg+ Day 28
|
63 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 2 CD3+ CD8+ IFNg+ Month 3
|
58 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 2 CD3+ CD8+ IFNg+ Month 6
|
51 Participants
|
|
Incidence of Immunogenicity Against CTL019 - Cellular Immunogenicity
CTL019 Pool 2 CD3+ CD8+ IFNg+ Month 12
|
34 Participants
|
SECONDARY outcome
Timeframe: Day 1 10 min post-infusion, Day 4, 7, 11, 14, 28Population: Cellular kinetic analysis set (CKAS) consisted of participants in the FAS who had at least 1 sample providing evaluable cellular kinetic data and had non-missing data
Area under the concentration-time curve of CTL019 in the peripheral blood after single dose administration from time zero to Day 28 after single dose administration as measured by qPCR.
Outcome measures
| Measure |
CTL019
n=57 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
AUC0-28d: PK Parameters for CTL019 by qPCR
|
365000 copies/ug*day
Geometric Coefficient of Variation 174.5
|
SECONDARY outcome
Timeframe: Day 1 10 min post-infusion, Day 4, 7, 11, 14, 28 and 84Population: Cellular kinetic analysis set (CKAS) consisted of participants in the FAS who had at least 1 sample providing evaluable cellular kinetic data and had non-missing data
Area under the concentration-time curve of CTL019 in the peripheral blood after single dose administration from time zero to Day 84 after single dose administration as measured by qPCR.
Outcome measures
| Measure |
CTL019
n=46 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
AUC0-84d: PK Parameters for CTL019 by qPCR
|
555000 Copies/ug*day
Geometric Coefficient of Variation 193.3
|
SECONDARY outcome
Timeframe: Day 1 10 min post-infusion, Day 4, 7, 11, 14, 28, Month 3, 6, 9 and 12Population: Cellular kinetic analysis set (CKAS) consisted of participants in the FAS who had at least 1 sample providing evaluable cellular kinetic data and had non-missing data
The maximum (peak) observed in peripheral blood drug concentration after single dose administration
Outcome measures
| Measure |
CTL019
n=62 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Cmax: PK Parameters for CTL019 by qPCR
|
35300 copies/ug
Geometric Coefficient of Variation 215.7
|
SECONDARY outcome
Timeframe: Day 1 10 min post-infusion, Day 4, 7, 11, 14, 28, Month 3, 6, 9 and 12Population: Cellular kinetic analysis set (CKAS) consisted of participants in the FAS who had at least 1 sample providing evaluable cellular kinetic data and had non-missing data
The last observed in peripheral blood drug concentration after single dose administration.
Outcome measures
| Measure |
CTL019
n=62 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Clast: PK Parameters for CTL019 by qPCR
|
240 copies/ug
Geometric Coefficient of Variation 147.3
|
SECONDARY outcome
Timeframe: Day 1 10 min post-infusion, Day 4, 7, 11, 14, 28, Month 3, 6, 9 and 12Population: Cellular kinetic analysis set (CKAS) consisted of participants in the FAS who had at least 1 sample providing evaluable cellular kinetic data and had non-missing data
The time to reach maximum (peak) peripheral blood drug concentration after single dose administration.
Outcome measures
| Measure |
CTL019
n=62 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Tmax: PK Parameters for CTL019 by qPCR
|
10.0 days
Interval 5.86 to 17.5
|
SECONDARY outcome
Timeframe: Day 1 10 min post-infusion, Day 4, 7, 11, 14, 28, Month 3, 6, 9 and 12Population: Cellular kinetic analysis set (CKAS) consisted of participants in the FAS who had at least 1 sample providing evaluable cellular kinetic data and had non-missing data
The half-life associated with the elimination phase slope of a semi logarithmic concentration-time curve (days) in peripheral blood.
Outcome measures
| Measure |
CTL019
n=35 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
T1/2: PK Parameters for CTL019 by qPCR
|
63.8 days
Geometric Coefficient of Variation 182.1
|
SECONDARY outcome
Timeframe: Day 1 10 min post-infusion, Day 4, 7, 11, 14, 28, Month 3, 6, 9 and 12Population: Cellular kinetic analysis set (CKAS) consisted of participants in the FAS who had at least 1 sample providing evaluable cellular kinetic data and had non-missing data
The time to reach the last observed quantifiable concentration in peripheral blood after single dose administration.
Outcome measures
| Measure |
CTL019
n=62 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Tlast: PK Parameters for CTL019 by qPCR
|
269 days
Interval 12.9 to 379.0
|
SECONDARY outcome
Timeframe: Day 1 10 min post-infusion, Day 4, 7, 11, 14, 28Population: Cellular kinetic analysis set (CKAS) consisted of participants in the FAS who had at least 1 sample providing evaluable cellular kinetic data and had non-missing data
AUC0-28d from time zero to Day 28 after single dose administration as measured by qPCR. PK results were presented by the maximum Penn Grading Scale (Grade 1 to 4): 1. \- Mild reaction 2. \- Moderate reaction 3. \- More severe reaction 4. \- Life-threatening complications
Outcome measures
| Measure |
CTL019
n=57 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
AUC0-28d by Maximum Cytokine Release Syndrome (CRS) Grade
Grade 3
|
643000 copies/ug*day
Geometric Coefficient of Variation 272.8
|
|
AUC0-28d by Maximum Cytokine Release Syndrome (CRS) Grade
Grade 4
|
890000 copies/ug*day
Geometric Coefficient of Variation 119.1
|
|
AUC0-28d by Maximum Cytokine Release Syndrome (CRS) Grade
No CRS
|
141000 copies/ug*day
Geometric Coefficient of Variation 130.6
|
|
AUC0-28d by Maximum Cytokine Release Syndrome (CRS) Grade
Grade 1/2
|
374000 copies/ug*day
Geometric Coefficient of Variation 72.6
|
SECONDARY outcome
Timeframe: Day 1 10 min post-infusion, Day 4, 7, 11, 14, 28, Month 3, 6, 9 and 12Population: Cellular kinetic analysis set (CKAS) consisted of participants in the FAS who had at least 1 sample providing evaluable cellular kinetic data and had non-missing data
The maximum (peak) observed in peripheral blood drug concentration after single dose administration. PK results were presented by the maximum Penn Grading Scale (Grade 1 to 4): 1. \- Mild reaction 2. \- Moderate reaction 3. \- More severe reaction 4. \- Life-threatening complications
Outcome measures
| Measure |
CTL019
n=62 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Cmax by Maximum Cytokine Release Syndrome (CRS) Grade
No CRS
|
16300 copies/ug
Geometric Coefficient of Variation 157.8
|
|
Cmax by Maximum Cytokine Release Syndrome (CRS) Grade
Grade 1/2
|
31200 copies/ug
Geometric Coefficient of Variation 199.3
|
|
Cmax by Maximum Cytokine Release Syndrome (CRS) Grade
Grade 3
|
66600 copies/ug
Geometric Coefficient of Variation 299.9
|
|
Cmax by Maximum Cytokine Release Syndrome (CRS) Grade
Grade 4
|
87900 copies/ug
Geometric Coefficient of Variation 84.9
|
POST_HOC outcome
Timeframe: Pre-treatment period: up to 81 days post signed informed consent; Post-treatment period: up to 24.4 months post CTL019 infusion (planned follow-up period per protocol was only 12 months post CTL019 infusion)Population: all enrolled participants
Deaths were reported in the pre-treatment period (without receiving a CTL019 infusion) and post-treatment period (after receiving a CTL019 infusion).
Outcome measures
| Measure |
CTL019
n=74 Participants
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Total Number of Deaths
Pre-treatment (without CTL019 infusion)
|
4 Participants
|
|
Total Number of Deaths
Post-treatment: ≤30 days (after CTL019 infusion)
|
4 Participants
|
|
Total Number of Deaths
Post-treatment: >30 days (after CTL019 infusion)
|
5 Participants
|
Adverse Events
All Subjects - CTL019
Serious events: 50 serious events
Other events: 66 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
All Subjects - CTL019
n=69 participants at risk
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
2.9%
2/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.9%
2/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Cardiac disorders
Left ventricular dysfunction
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Cardiac disorders
Tachycardia
|
2.9%
2/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
General disorders
Drug withdrawal syndrome
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
General disorders
Pyrexia
|
15.9%
11/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Immune system disorders
Cytokine release syndrome
|
40.6%
28/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Alternaria infection
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Aspergillus infection
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Bacterial infection
|
2.9%
2/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Candida infection
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Cellulitis
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Cellulitis orbital
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Central nervous system infection
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Cerebral fungal infection
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Device related infection
|
2.9%
2/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Enterococcal infection
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Herpes zoster
|
4.3%
3/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Infection
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Influenza
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Meningitis aseptic
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Periorbital cellulitis
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Pneumonia
|
2.9%
2/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Pneumonia haemophilus
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Sepsis
|
4.3%
3/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Septic shock
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Sinusitis
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Tonsillitis
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Injury, poisoning and procedural complications
Splinter
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Investigations
Blood fibrinogen decreased
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Investigations
Chest X-ray abnormal
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Investigations
Immunoglobulins decreased
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Investigations
Platelet count decreased
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent
|
4.3%
3/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B precursor type acute leukaemia
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Nervous system disorders
Depressed level of consciousness
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Nervous system disorders
Dysarthria
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Nervous system disorders
Dyskinesia
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Nervous system disorders
Encephalopathy
|
2.9%
2/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Nervous system disorders
Facial paralysis
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Nervous system disorders
Seizure
|
2.9%
2/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Nervous system disorders
Somnolence
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Nervous system disorders
Tremor
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Psychiatric disorders
Agitation
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Psychiatric disorders
Completed suicide
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Psychiatric disorders
Confusional state
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Psychiatric disorders
Disorientation
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Psychiatric disorders
Hallucination
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Psychiatric disorders
Irritability
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
2/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Vascular disorders
Jugular vein thrombosis
|
1.4%
1/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
Other adverse events
| Measure |
All Subjects - CTL019
n=69 participants at risk
CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10\^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.3%
14/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.8%
4/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.5%
10/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.2%
5/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Cardiac disorders
Sinus tachycardia
|
5.8%
4/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Cardiac disorders
Tachycardia
|
11.6%
8/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.6%
8/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.8%
4/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Gastrointestinal disorders
Constipation
|
10.1%
7/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Gastrointestinal disorders
Diarrhoea
|
24.6%
17/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Gastrointestinal disorders
Nausea
|
23.2%
16/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
13/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
General disorders
Chills
|
5.8%
4/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
General disorders
Face oedema
|
8.7%
6/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
General disorders
Fatigue
|
10.1%
7/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
General disorders
Oedema peripheral
|
7.2%
5/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
General disorders
Pain
|
7.2%
5/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
General disorders
Pyrexia
|
34.8%
24/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Immune system disorders
Allergy to immunoglobulin therapy
|
5.8%
4/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Immune system disorders
Cytokine release syndrome
|
43.5%
30/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
30.4%
21/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Nasopharyngitis
|
13.0%
9/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Rhinitis
|
7.2%
5/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.1%
7/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Investigations
Alanine aminotransferase increased
|
10.1%
7/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Investigations
Aspartate aminotransferase increased
|
11.6%
8/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Investigations
Blood fibrinogen decreased
|
5.8%
4/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Investigations
Immunoglobulins decreased
|
7.2%
5/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Investigations
Lymphocyte count decreased
|
7.2%
5/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Investigations
Neutrophil count decreased
|
15.9%
11/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Investigations
Platelet count decreased
|
14.5%
10/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Investigations
White blood cell count decreased
|
20.3%
14/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.6%
8/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.8%
4/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.8%
4/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.6%
8/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.6%
8/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.3%
14/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.1%
7/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
14.5%
10/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.6%
8/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
6/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.7%
6/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.1%
7/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Nervous system disorders
Headache
|
23.2%
16/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Nervous system disorders
Seizure
|
5.8%
4/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Psychiatric disorders
Anxiety
|
5.8%
4/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Psychiatric disorders
Insomnia
|
7.2%
5/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Renal and urinary disorders
Haematuria
|
5.8%
4/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.3%
14/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.6%
8/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.1%
7/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.8%
4/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.7%
6/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.2%
5/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.7%
6/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
8.7%
6/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.6%
8/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.5%
10/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Vascular disorders
Hypertension
|
11.6%
8/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
|
Vascular disorders
Hypotension
|
8.7%
6/69 • Treatment-emergent adverse events were collected from CTL019 infusion, until approximately 12 months post infusion. For all-cause mortality, the data are presented from CTL019 infusion up to 24.4 months post infusion.
Any signs or symptoms that occurred from CTL019 infusion until end of study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER