Trial Outcomes & Findings for Redirected Auto T Cells for Advanced Myeloma (NCT NCT01352286)

NCT ID: NCT01352286

Last Updated: 2019-12-03

Results Overview

Number of Participants with Adverse Events related to study treatment

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Day -40 to Year 1 post-treatment

Results posted on

2019-12-03

Participant Flow

Participant milestones

Participant milestones
Measure
NYESO-1ᶜ²⁵⁹T Cells Administered Intravenously
Participants who received lentivirus-mediated genetically engineered NYESO-1ᶜ²⁵⁹T following autologous stem cell transplantation (ASCT)
Overall Study
STARTED
25
Overall Study
Received T-cells
25
Overall Study
COMPLETED
25
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Redirected Auto T Cells for Advanced Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
NYESO-1ᶜ²⁵⁹T Cells
n=25 Participants
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
17 Participants
n=5 Participants
Age, Categorical
>=65 years
8 Participants
n=5 Participants
Age, Continuous
59 years
n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
Sex: Female, Male
Male
15 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=5 Participants
Race (NIH/OMB)
White
19 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Day -40 to Year 1 post-treatment

Population: Participants who received NYESO-1ᶜ²⁵⁹T following ASCT

Number of Participants with Adverse Events related to study treatment

Outcome measures

Outcome measures
Measure
NYESO-1ᶜ²⁵⁹T Cells
n=25 Participants
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Adverse Events Related to Study Treatment
24 participants

SECONDARY outcome

Timeframe: Change from Baseline at Day 42, 100, 180, 270 and Year 1

Population: Participants who received NYESO-1ᶜ²⁵⁹T following ASCT

Objective Response Rate (ORR) of sCR (stringent complete response), CR (complete response), VGPR (very good partial response), PR (partial response)

Outcome measures

Outcome measures
Measure
NYESO-1ᶜ²⁵⁹T Cells
n=25 Participants
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Number of Participants With Response Per International Myeloma Working Group (IMWG) 2011 Criteria
Day 42
20 Participants
Number of Participants With Response Per International Myeloma Working Group (IMWG) 2011 Criteria
Day 100
19 Participants
Number of Participants With Response Per International Myeloma Working Group (IMWG) 2011 Criteria
Day 180
16 Participants
Number of Participants With Response Per International Myeloma Working Group (IMWG) 2011 Criteria
Day 270
13 Participants
Number of Participants With Response Per International Myeloma Working Group (IMWG) 2011 Criteria
Year 1
11 Participants

SECONDARY outcome

Timeframe: Best Objective Response prior to initiation of lenalidomide and at Year 1

Population: Participants who received NYESO-1ᶜ²⁵⁹T following ASCT with Best Objective Response (BOR) data.

Number of participants with Best Objective Response of sCR, CR, VGPR, or PR

Outcome measures

Outcome measures
Measure
NYESO-1ᶜ²⁵⁹T Cells
n=25 Participants
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Best Objective Response (BOR)
Prior to Initiation of Lenalidomide : sCR
1 Participants
Best Objective Response (BOR)
Prior to Initiation of Lenalidomide : CR
0 Participants
Best Objective Response (BOR)
Prior to Initiation of Lenalidomide : VGPR
12 Participants
Best Objective Response (BOR)
Prior to Initiation of Lenalidomide : PR
7 Participants
Best Objective Response (BOR)
Year 1 : sCR
2 Participants
Best Objective Response (BOR)
Year 1 : CR
1 Participants
Best Objective Response (BOR)
Year 1 : VGPR
13 Participants
Best Objective Response (BOR)
Year 1 : PR
5 Participants

SECONDARY outcome

Timeframe: DOR: Initial date of response to date of progressive disease or death PFS: Date of first T -cell infusion to earliest date of disease progression of death due to any cause OS: Date of first T-cell infusion to date of death from any cause.

Population: Participants who received NYESO-1ᶜ²⁵⁹T following ASCT

Calculated median DOR, PFS, OS

Outcome measures

Outcome measures
Measure
NYESO-1ᶜ²⁵⁹T Cells
n=25 Participants
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Duration of Response (DOR), Progression Free Survival (PFS), Overall Survival (OS)
PFS
13.5 median months
Interval 8.9 to 31.1
Duration of Response (DOR), Progression Free Survival (PFS), Overall Survival (OS)
DOR
12.2 median months
Interval 7.6 to 29.8
Duration of Response (DOR), Progression Free Survival (PFS), Overall Survival (OS)
OS
35.1 median months
Interval 22.7 to
The 95% upper confidence limits for median overall survival could not be calculated because of the high number/proportion (11 participants/44%) of participants alive at the time of the analysis.

SECONDARY outcome

Timeframe: Post-infusion through Day 42

Population: Participants who received NYESO-1ᶜ²⁵⁹T following ASCT

Measurement of NY-ESO-1ᶜ²⁵⁹T cells in blood

Outcome measures

Outcome measures
Measure
NYESO-1ᶜ²⁵⁹T Cells
n=25 Participants
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Peak Persistence of Modified T-cells in the Peripheral Blood
143728.793 copies per μg of DNA
Interval 7560.1 to 284312.37

SECONDARY outcome

Timeframe: Pre- and post-infusion

Population: Participants who received NYESO-1ᶜ²⁵⁹T following ASCT with expression data at all points.

Number of participants with NY-ESO-1 and LAGE or LAGE-1a expression in the marrow post-infusion

Outcome measures

Outcome measures
Measure
NYESO-1ᶜ²⁵⁹T Cells
n=25 Participants
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Marrow Antigen Expression Pre-and Post-infusion
Day 100 : LAGE or LAGE-1a
16 participants
Marrow Antigen Expression Pre-and Post-infusion
Day 180 : NY-ESO-1
14 participants
Marrow Antigen Expression Pre-and Post-infusion
Day 180 : LAGE or LAGE-1a
14 participants
Marrow Antigen Expression Pre-and Post-infusion
Day 100 : NY-ESO-1
16 participants

SECONDARY outcome

Timeframe: Post Treatment

Population: Participants who received NYESO-1ᶜ²⁵⁹T following ASCT with engraftment data.

Number of participants with engraftment in blood and bone marrow

Outcome measures

Outcome measures
Measure
NYESO-1ᶜ²⁵⁹T Cells
n=25 Participants
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Engraftment of Gene-modified Pentamer+ CD4+ T Cells and CD8+ T Cells
CD4+ : Blood
11 participants
Engraftment of Gene-modified Pentamer+ CD4+ T Cells and CD8+ T Cells
CD4+ : Bone Marrow
11 participants
Engraftment of Gene-modified Pentamer+ CD4+ T Cells and CD8+ T Cells
CD8+ : Blood
11 participants
Engraftment of Gene-modified Pentamer+ CD4+ T Cells and CD8+ T Cells
CD8+ : Bone Marrow
11 participants

Adverse Events

NYESO-1ᶜ²⁵⁹T Cells

Serious events: 17 serious events
Other events: 25 other events
Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure
NYESO-1ᶜ²⁵⁹T Cells
n=25 participants at risk
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Investigations
Myoglobin blood
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Cardiac disorders
Atrial fibrillation
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Blood and lymphatic system disorders
Febrile neutropenia
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Blood and lymphatic system disorders
Neutropenia
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
General disorders
Pyrexia
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Immune system disorders
Graft versus host disease
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Hypoxia
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Staphylococcal infection
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Renal and urinary disorders
Acute Kidney Injury
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
General disorders
Asthenia
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Immune system disorders
Autoimmune disorder
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
Blood creatine phosphokinase increased
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
Blood lactate dehydrogenase increased
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Colitis
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Respiratory, thoracic and mediastinal disorders
Cough
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Vascular disorders
Deep vein thrombosis
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Dehydration
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Respiratory, thoracic and mediastinal disorders
Dyspnea
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
Ejection Fraction
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Failure to Thrive
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Graft versus host disease in gastrointestinal tract
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Injury, poisoning and procedural complications
Hip Fracture
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Hepatic infection
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Renal and urinary disorders
Hydronephrosis
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Hypercalcaemia
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Hyponatraemia
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Vascular disorders
Hypotension
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Influenza
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Klebsiella infection
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Blood and lymphatic system disorders
Leukopenia
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
Myoglobin urine
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Neutropenic sepsis
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
Neutrophil count decreased
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
Platelet count decreased
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Respiratory, thoracic and mediastinal disorders
Pneumonitis
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Nervous system disorders
Syncope
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Viral upper respiratory tract infection
4.0%
1/25 • Number of events 1 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT

Other adverse events

Other adverse events
Measure
NYESO-1ᶜ²⁵⁹T Cells
n=25 participants at risk
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Nausea
100.0%
25/25 • Number of events 25 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Blood and lymphatic system disorders
Anaemia
96.0%
24/25 • Number of events 24 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Diarrhea
96.0%
24/25 • Number of events 24 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Decreased appetite
92.0%
23/25 • Number of events 23 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Blood and lymphatic system disorders
Thrombocytopenia
72.0%
18/25 • Number of events 18 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
Platelet count decreased
48.0%
12/25 • Number of events 12 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
General disorders
Fatigue
88.0%
22/25 • Number of events 22 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Skin and subcutaneous tissue disorders
Rash maculo-papular
80.0%
20/25 • Number of events 20 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Skin and subcutaneous tissue disorders
Erythema multiforme
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
General disorders
Pyrexia
80.0%
20/25 • Number of events 20 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Hypokalemia
76.0%
19/25 • Number of events 19 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Vomiting
76.0%
19/25 • Number of events 19 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Blood and lymphatic system disorders
Febrile neutropenia
64.0%
16/25 • Number of events 16 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Musculoskeletal and connective tissue disorders
Back pain
60.0%
15/25 • Number of events 15 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Blood and lymphatic system disorders
Leukopenia
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
WBC decreased
52.0%
13/25 • Number of events 13 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Blood and lymphatic system disorders
Neutropenia
32.0%
8/25 • Number of events 8 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
Neutrophil count decreased
32.0%
8/25 • Number of events 8 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Respiratory, thoracic and mediastinal disorders
Cough
56.0%
14/25 • Number of events 14 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Hypocalcaemia
56.0%
14/25 • Number of events 14 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
General disorders
Oedema peripheral
56.0%
14/25 • Number of events 14 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Stomatitis
56.0%
14/25 • Number of events 14 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Abdominal pain
52.0%
13/25 • Number of events 13 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Respiratory, thoracic and mediastinal disorders
Dyspnea
52.0%
13/25 • Number of events 13 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Constipation
48.0%
12/25 • Number of events 12 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Hyperglycemia
48.0%
12/25 • Number of events 12 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Hypomagnesaemia
48.0%
12/25 • Number of events 12 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Hypophosphataemia
48.0%
12/25 • Number of events 12 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Musculoskeletal and connective tissue disorders
Muscular weakness
48.0%
12/25 • Number of events 12 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Nervous system disorders
Headache
44.0%
11/25 • Number of events 11 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Upper respiratory tract infection
44.0%
11/25 • Number of events 11 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
General disorders
Chills
40.0%
10/25 • Number of events 10 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Vascular disorders
Hypotension
36.0%
9/25 • Number of events 9 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Musculoskeletal and connective tissue disorders
Pain in extremity
36.0%
9/25 • Number of events 9 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Hypoalbuminaemia
32.0%
8/25 • Number of events 8 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Psychiatric disorders
Insomnia
32.0%
8/25 • Number of events 8 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
32.0%
8/25 • Number of events 8 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Hyponatraemia
28.0%
7/25 • Number of events 7 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Oral Pain
28.0%
7/25 • Number of events 7 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
General disorders
Pain
28.0%
7/25 • Number of events 7 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
Alanine aminotransferase increased
24.0%
6/25 • Number of events 6 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Psychiatric disorders
Anxiety
24.0%
6/25 • Number of events 6 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Musculoskeletal and connective tissue disorders
Arthralgia
24.0%
6/25 • Number of events 6 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Nervous system disorders
Dizziness
24.0%
6/25 • Number of events 6 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
24.0%
6/25 • Number of events 6 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Musculoskeletal and connective tissue disorders
Neck Pain
24.0%
6/25 • Number of events 6 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Cardiac disorders
Tachycardia
24.0%
6/25 • Number of events 6 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
Blood alkaline phosphatase increased
20.0%
5/25 • Number of events 5 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Candida infection
20.0%
5/25 • Number of events 5 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Immune system disorders
Graft Versus Host Disease (GVHD)
16.0%
4/25 • Number of events 4 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
General disorders
Localized edema
20.0%
5/25 • Number of events 5 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
Lymphocyte count decreased
20.0%
5/25 • Number of events 5 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Nervous system disorders
Peripheral sensory neuropathy
20.0%
5/25 • Number of events 5 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Cardiac disorders
Sinus tachycardia
20.0%
5/25 • Number of events 5 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Abdominal distension
16.0%
4/25 • Number of events 4 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Skin and subcutaneous tissue disorders
Alopecia
16.0%
4/25 • Number of events 4 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
Aspartate aminotransferase increased
16.0%
4/25 • Number of events 4 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
Blood creatinine increased
16.0%
4/25 • Number of events 4 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Psychiatric disorders
Depression
16.0%
4/25 • Number of events 4 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Musculoskeletal and connective tissue disorders
Flank pain
16.0%
4/25 • Number of events 4 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Herpes zoster
16.0%
4/25 • Number of events 4 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Vascular disorders
Hypertension
16.0%
4/25 • Number of events 4 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Hypoglycemia
16.0%
4/25 • Number of events 4 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
General disorders
Mucosal inflammation
16.0%
4/25 • Number of events 4 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Musculoskeletal and connective tissue disorders
Muscle spasms
16.0%
4/25 • Number of events 4 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Oesophagitis
16.0%
4/25 • Number of events 4 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Nervous system disorders
Paresthesia
16.0%
4/25 • Number of events 4 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Skin and subcutaneous tissue disorders
Pruritus
16.0%
4/25 • Number of events 4 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
Weight decreased
16.0%
4/25 • Number of events 4 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Renal and urinary disorders
Acute kidney injury
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Cardiac disorders
Atrial fibrillation
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Immune system disorders
Autoimmune disorder
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
Blood creatinine decreased
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
General disorders
Catheter site pain
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Clostridium difficile infection
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Psychiatric disorders
Confusional state
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Dry Mouth
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Nervous system disorders
Dysgeusia
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Respiratory, thoracic and mediastinal disorders
Hiccups
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Skin and subcutaneous tissue disorders
Hyperhidrosis
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Hyperkalaemia
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Hypernatraemia
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
General disorders
Malaise
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Mouth ulceration
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Musculoskeletal and connective tissue disorders
Myalgia
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Nervous system disorders
Neuralgia
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Neutropenic colitis
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Oral candidiasis
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Oral dysaesthesia
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Nervous system disorders
Peripheral motor neuropathy
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Pneumonia
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Respiratory, thoracic and mediastinal disorders
Rales
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Respiratory, thoracic and mediastinal disorders
Tachypnoea
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Nervous system disorders
Tremor
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Respiratory, thoracic and mediastinal disorders
Wheezing
12.0%
3/25 • Number of events 3 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Abdominal tenderness
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Psychiatric disorders
Agitation
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
Blood bilirubin increased
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
General disorders
Catheter site discharge
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
General disorders
Catheter site hemorrhage
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
General disorders
Chest discomfort
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Clostridium difficile colitis
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Injury, poisoning and procedural complications
Contusion
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Dehydration
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Psychiatric disorders
Delirium
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Diverticulitis
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Skin and subcutaneous tissue disorders
Dry skin
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Dysphagia
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Skin and subcutaneous tissue disorders
Ecchymosis
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Skin and subcutaneous tissue disorders
Erythema
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
General disorders
Face edema
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Injury, poisoning and procedural complications
Fall
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Vascular disorders
Flushing
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Gastrointestinal disorders
Gastroesophageal reflux disease
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Renal and urinary disorders
Haematuria
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Hypercalcaemia
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Hypermagnesaemia
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Investigations
International normalized ratio increased
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Metabolism and nutrition disorders
Malnutrition
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Nervous system disorders
Neuropathy peripheral
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Cardiac disorders
Palpitations
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
General disorders
Peripheral swelling
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Skin and subcutaneous tissue disorders
Petechiae
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Respiratory, thoracic and mediastinal disorders
Pneumonitis
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Respiratory, thoracic and mediastinal disorders
Productive cough
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Skin and subcutaneous tissue disorders
Purpura
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Renal and urinary disorders
Renal failure
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Skin and subcutaneous tissue disorders
Scab
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Nervous system disorders
Sinus headache
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Respiratory, thoracic and mediastinal disorders
Sinus pain
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Sinusitis
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Skin and subcutaneous tissue disorders
Skin disorder
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Skin and subcutaneous tissue disorders
Skin ulcer
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Staphylococcal infection
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Tooth abscess
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Tooth infection
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Renal and urinary disorders
Urinary incontinence
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Cardiac disorders
Ventricular tachycardia
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Infections and infestations
Viral upper respiratory tract infection
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Eye disorders
Vision blurred
8.0%
2/25 • Number of events 2 • Day -40 to Year 1 post-treatment
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60