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Redirected Auto T Cells for Advanced Myeloma

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ClinicalTrials.gov Identifier: NCT01352286
Recruitment Status : Active, not recruiting
First Posted : May 11, 2011
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Intervention Genetic: Autologous Genetically modified T cells
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NYESO-1ᶜ²⁵⁹T Cells Administered Intravenously
Hide Arm/Group Description Participants who received lentivirus-mediated genetically engineered NYESO-1ᶜ²⁵⁹T following autologous stem cell transplantation (ASCT)
Period Title: Overall Study
Started 25
Received T-cells 25
Completed 25
Not Completed 0
Arm/Group Title NYESO-1ᶜ²⁵⁹T Cells
Hide Arm/Group Description Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  68.0%
>=65 years
8
  32.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants
59
(45 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
10
  40.0%
Male
15
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
25
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  20.0%
White
19
  76.0%
More than one race
1
   4.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Adverse Events Related to Study Treatment
Hide Description Number of Participants with Adverse Events related to study treatment
Time Frame Day -40 to Year 1 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Arm/Group Title NYESO-1ᶜ²⁵⁹T Cells
Hide Arm/Group Description:
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
24
2.Secondary Outcome
Title Number of Participants With Response Per International Myeloma Working Group (IMWG) 2011 Criteria
Hide Description Objective Response Rate (ORR) of sCR (stringent complete response), CR (complete response), VGPR (very good partial response), PR (partial response)
Time Frame Change from Baseline at Day 42, 100, 180, 270 and Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Arm/Group Title NYESO-1ᶜ²⁵⁹T Cells
Hide Arm/Group Description:
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
Day 42
20
  80.0%
Day 100
19
  76.0%
Day 180
16
  64.0%
Day 270
13
  52.0%
Year 1
11
  44.0%
3.Secondary Outcome
Title Best Objective Response (BOR)
Hide Description Number of participants with Best Objective Response of sCR, CR, VGPR, or PR
Time Frame Best Objective Response prior to initiation of lenalidomide and at Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT with Best Objective Response (BOR) data.
Arm/Group Title NYESO-1ᶜ²⁵⁹T Cells
Hide Arm/Group Description:
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
Prior to Initiation of Lenalidomide : sCR
1
   4.0%
Prior to Initiation of Lenalidomide : CR
0
   0.0%
Prior to Initiation of Lenalidomide : VGPR
12
  48.0%
Prior to Initiation of Lenalidomide : PR
7
  28.0%
Year 1 : sCR
2
   8.0%
Year 1 : CR
1
   4.0%
Year 1 : VGPR
13
  52.0%
Year 1 : PR
5
  20.0%
4.Secondary Outcome
Title Duration of Response (DOR), Progression Free Survival (PFS), Overall Survival (OS)
Hide Description Calculated median DOR, PFS, OS
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Arm/Group Title NYESO-1ᶜ²⁵⁹T Cells
Hide Arm/Group Description:
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: median months
DOR
12.2
(7.6 to 29.8)
PFS
13.5
(8.9 to 31.1)
OS
35.1 [1] 
(22.7 to NA)
[1]
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.
5.Secondary Outcome
Title Peak Persistence of Modified T-cells in the Peripheral Blood
Hide Description Measurement of NY-ESO-1ᶜ²⁵⁹T cells in blood
Time Frame Post-infusion through Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Arm/Group Title NYESO-1ᶜ²⁵⁹T Cells
Hide Arm/Group Description:
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Overall Number of Participants Analyzed 25
Mean (Full Range)
Unit of Measure: copies per μg of DNA
143728.793
(7560.10 to 284312.37)
6.Secondary Outcome
Title Marrow Antigen Expression Pre-and Post-infusion
Hide Description Number of participants with NY-ESO-1 and LAGE or LAGE-1a expression in the marrow post-infusion
Time Frame Pre- and post-infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT with expression data at all points.
Arm/Group Title NYESO-1ᶜ²⁵⁹T Cells
Hide Arm/Group Description:
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT with data at pre-and post-infusion time points
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
Day 100 : NY-ESO-1 16
Day 100 : LAGE or LAGE-1a 16
Day 180 : NY-ESO-1 14
Day 180 : LAGE or LAGE-1a 14
7.Secondary Outcome
Title Engraftment of Gene-modified Pentamer+ CD4+ T Cells and CD8+ T Cells
Hide Description Number of participants with engraftment in blood and bone marrow
Time Frame Post Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT with engraftment data.
Arm/Group Title NYESO-1ᶜ²⁵⁹T Cells
Hide Arm/Group Description:
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
CD4+ : Blood 11
CD4+ : Bone Marrow 11
CD8+ : Blood 11
CD8+ : Bone Marrow 11
Time Frame Day -40 to Year 1 post-treatment
Adverse Event Reporting Description Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT
 
Arm/Group Title NYESO-1ᶜ²⁵⁹T Cells
Hide Arm/Group Description Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
All-Cause Mortality
NYESO-1ᶜ²⁵⁹T Cells
Affected / at Risk (%)
Total   14/25 (56.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
NYESO-1ᶜ²⁵⁹T Cells
Affected / at Risk (%) # Events
Total   17/25 (68.00%)    
Blood and lymphatic system disorders   
Febrile neutropenia * 1  3/25 (12.00%)  3
Neutropenia * 1  3/25 (12.00%)  3
Leukopenia * 1  1/25 (4.00%)  1
Cardiac disorders   
Atrial fibrillation * 1  3/25 (12.00%)  3
Gastrointestinal disorders   
Hypoxia * 1  2/25 (8.00%)  2
Colitis * 1  1/25 (4.00%)  1
Graft versus host disease in gastrointestinal tract * 1  1/25 (4.00%)  1
General disorders   
Pyrexia * 1  3/25 (12.00%)  3
Asthenia * 1  1/25 (4.00%)  1
Immune system disorders   
Graft versus host disease * 1  2/25 (8.00%)  2
Autoimmune disorder * 1  1/25 (4.00%)  1
Infections and infestations   
Staphylococcal infection * 1  2/25 (8.00%)  2
Hepatic infection * 1  1/25 (4.00%)  1
Influenza * 1  1/25 (4.00%)  1
Klebsiella infection * 1  1/25 (4.00%)  1
Neutropenic sepsis * 1  1/25 (4.00%)  1
Viral upper respiratory tract infection * 1  1/25 (4.00%)  1
Injury, poisoning and procedural complications   
Hip Fracture * 1  1/25 (4.00%)  1
Investigations   
Blood creatine phosphokinase increased * 1  1/25 (4.00%)  1
Blood lactate dehydrogenase increased * 1  1/25 (4.00%)  1
Ejection Fraction * 1  1/25 (4.00%)  1
Myoglobin blood * 1  1/25 (4.00%)  1
Myoglobin urine * 1  1/25 (4.00%)  1
Neutrophil count decreased * 1  1/25 (4.00%)  1
Platelet count decreased * 1  1/25 (4.00%)  1
Metabolism and nutrition disorders   
Dehydration * 1  1/25 (4.00%)  1
Failure to Thrive * 1  1/25 (4.00%)  1
Hypercalcaemia * 1  1/25 (4.00%)  1
Hyponatraemia * 1  1/25 (4.00%)  1
Musculoskeletal and connective tissue disorders   
Rhabdomyolysis * 1  1/25 (4.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Plasmacytoma * 1  1/25 (4.00%)  1
Nervous system disorders   
Syncope * 1  1/25 (4.00%)  1
Renal and urinary disorders   
Acute Kidney Injury * 1  1/25 (4.00%)  1
Hydronephrosis * 1  1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/25 (4.00%)  1
Dyspnea * 1  1/25 (4.00%)  1
Pneumonitis * 1  1/25 (4.00%)  1
Pulmonary edema * 1  1/25 (4.00%)  1
Vascular disorders   
Deep vein thrombosis * 1  1/25 (4.00%)  1
Hypotension * 1  1/25 (4.00%)  1
1
Term from vocabulary, MedDRA version 20
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NYESO-1ᶜ²⁵⁹T Cells
Affected / at Risk (%) # Events
Total   25/25 (100.00%)    
Blood and lymphatic system disorders   
Anaemia * 1  24/25 (96.00%)  24
Thrombocytopenia * 1  18/25 (72.00%)  18
Febrile neutropenia * 1  16/25 (64.00%)  16
Leukopenia * 1  2/25 (8.00%)  2
Neutropenia * 1  8/25 (32.00%)  8
Cardiac disorders   
Tachycardia * 1  6/25 (24.00%)  6
Sinus tachycardia * 1  5/25 (20.00%)  5
Atrial fibrillation * 1  3/25 (12.00%)  3
Palpitations * 1  2/25 (8.00%)  2
Ventricular tachycardia * 1  2/25 (8.00%)  2
Eye disorders   
Vision blurred * 1  2/25 (8.00%)  2
Gastrointestinal disorders   
Nausea * 1  25/25 (100.00%)  25
Diarrhea * 1  24/25 (96.00%)  24
Vomiting * 1  19/25 (76.00%)  19
Stomatitis * 1  14/25 (56.00%)  14
Abdominal pain * 1  13/25 (52.00%)  13
Constipation * 1  12/25 (48.00%)  12
Oral Pain * 1  7/25 (28.00%)  7
Abdominal distension * 1  4/25 (16.00%)  4
Oesophagitis * 1  4/25 (16.00%)  4
Dry Mouth * 1  3/25 (12.00%)  3
Mouth ulceration * 1  3/25 (12.00%)  3
Neutropenic colitis * 1  3/25 (12.00%)  3
Oral dysaesthesia * 1  3/25 (12.00%)  3
Abdominal tenderness * 1  2/25 (8.00%)  2
Dysphagia * 1  2/25 (8.00%)  2
Gastroesophageal reflux disease * 1  2/25 (8.00%)  2
General disorders   
Fatigue * 1  22/25 (88.00%)  22
Pyrexia * 1  20/25 (80.00%)  20
Oedema peripheral * 1  14/25 (56.00%)  14
Chills * 1  10/25 (40.00%)  10
Pain * 1  7/25 (28.00%)  7
Localized edema * 1  5/25 (20.00%)  5
Mucosal inflammation * 1  4/25 (16.00%)  4
Catheter site pain * 1  3/25 (12.00%)  3
Malaise * 1  3/25 (12.00%)  3
Catheter site discharge * 1  2/25 (8.00%)  2
Catheter site hemorrhage * 1  2/25 (8.00%)  2
Chest discomfort * 1  2/25 (8.00%)  2
Face edema * 1  2/25 (8.00%)  2
Peripheral swelling * 1  2/25 (8.00%)  2
Immune system disorders   
Graft Versus Host Disease (GVHD) * 1  4/25 (16.00%)  4
Autoimmune disorder * 1  3/25 (12.00%)  3
Infections and infestations   
Upper respiratory tract infection * 1  11/25 (44.00%)  11
Candida infection * 1  5/25 (20.00%)  5
Herpes zoster * 1  4/25 (16.00%)  4
Clostridium difficile infection * 1  3/25 (12.00%)  3
Oral candidiasis * 1  3/25 (12.00%)  3
Pneumonia * 1  3/25 (12.00%)  3
Clostridium difficile colitis * 1  2/25 (8.00%)  2
Diverticulitis * 1  2/25 (8.00%)  2
Sinusitis * 1  2/25 (8.00%)  2
Staphylococcal infection * 1  2/25 (8.00%)  2
Tooth abscess * 1  2/25 (8.00%)  2
Tooth infection * 1  2/25 (8.00%)  2
Viral upper respiratory tract infection * 1  2/25 (8.00%)  2
Injury, poisoning and procedural complications   
Contusion * 1  2/25 (8.00%)  2
Fall * 1  2/25 (8.00%)  2
Investigations   
Platelet count decreased * 1  12/25 (48.00%)  12
WBC decreased * 1  13/25 (52.00%)  13
Neutrophil count decreased * 1  8/25 (32.00%)  8
Alanine aminotransferase increased * 1  6/25 (24.00%)  6
Blood alkaline phosphatase increased * 1  5/25 (20.00%)  5
Lymphocyte count decreased * 1  5/25 (20.00%)  5
Aspartate aminotransferase increased * 1  4/25 (16.00%)  4
Blood creatinine increased * 1  4/25 (16.00%)  4
Weight decreased * 1  4/25 (16.00%)  4
Blood creatinine decreased * 1  3/25 (12.00%)  3
Blood bilirubin increased * 1  2/25 (8.00%)  2
International normalized ratio increased * 1  2/25 (8.00%)  2
Metabolism and nutrition disorders   
Decreased appetite * 1  23/25 (92.00%)  23
Hypokalemia * 1  19/25 (76.00%)  19
Hypocalcaemia * 1  14/25 (56.00%)  14
Hyperglycemia * 1  12/25 (48.00%)  12
Hypomagnesaemia * 1  12/25 (48.00%)  12
Hypophosphataemia * 1  12/25 (48.00%)  12
Hypoalbuminaemia * 1  8/25 (32.00%)  8
Hyponatraemia * 1  7/25 (28.00%)  7
Hypoglycemia * 1  4/25 (16.00%)  4
Hyperkalaemia * 1  3/25 (12.00%)  3
Hypernatraemia * 1  3/25 (12.00%)  3
Dehydration * 1  2/25 (8.00%)  2
Hypercalcaemia * 1  2/25 (8.00%)  2
Hypermagnesaemia * 1  2/25 (8.00%)  2
Malnutrition * 1  2/25 (8.00%)  2
Musculoskeletal and connective tissue disorders   
Back pain * 1  15/25 (60.00%)  15
Muscular weakness * 1  12/25 (48.00%)  12
Pain in extremity * 1  9/25 (36.00%)  9
Arthralgia * 1  6/25 (24.00%)  6
Musculoskeletal chest pain * 1  6/25 (24.00%)  6
Neck Pain * 1  6/25 (24.00%)  6
Flank pain * 1  4/25 (16.00%)  4
Muscle spasms * 1  4/25 (16.00%)  4
Musculoskeletal pain * 1  3/25 (12.00%)  3
Myalgia * 1  3/25 (12.00%)  3
Joint range of motion decreased * 1  2/25 (8.00%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Plasmacytoma * 1  2/25 (8.00%)  2
Nervous system disorders   
Headache * 1  11/25 (44.00%)  11
Dizziness * 1  6/25 (24.00%)  6
Peripheral sensory neuropathy * 1  5/25 (20.00%)  5
Paresthesia * 1  4/25 (16.00%)  4
Dysgeusia * 1  3/25 (12.00%)  3
Neuralgia * 1  3/25 (12.00%)  3
Peripheral motor neuropathy * 1  3/25 (12.00%)  3
Tremor * 1  3/25 (12.00%)  3
Neuropathy peripheral * 1  2/25 (8.00%)  2
Sinus headache * 1  2/25 (8.00%)  2
Psychiatric disorders   
Insomnia * 1  8/25 (32.00%)  8
Anxiety * 1  6/25 (24.00%)  6
Depression * 1  4/25 (16.00%)  4
Confusional state * 1  3/25 (12.00%)  3
Agitation * 1  2/25 (8.00%)  2
Delirium * 1  2/25 (8.00%)  2
Renal and urinary disorders   
Acute kidney injury * 1  3/25 (12.00%)  3
Haematuria * 1  2/25 (8.00%)  2
Renal failure * 1  2/25 (8.00%)  2
Urinary incontinence * 1  2/25 (8.00%)  2
Respiratory, thoracic and mediastinal disorders   
Cough * 1  14/25 (56.00%)  14
Dyspnea * 1  13/25 (52.00%)  13
Oropharyngeal pain * 1  8/25 (32.00%)  8
Hiccups * 1  3/25 (12.00%)  3
Rales * 1  3/25 (12.00%)  3
Tachypnoea * 1  3/25 (12.00%)  3
Wheezing * 1  3/25 (12.00%)  3
Dyspnea exertional * 1  2/25 (8.00%)  2
Pneumonitis * 1  2/25 (8.00%)  2
Productive cough * 1  2/25 (8.00%)  2
Sinus pain * 1  2/25 (8.00%)  2
Skin and subcutaneous tissue disorders   
Rash maculo-papular * 1  20/25 (80.00%)  20
Erythema multiforme * 1  2/25 (8.00%)  2
Alopecia * 1  4/25 (16.00%)  4
Pruritus * 1  4/25 (16.00%)  4
Hyperhidrosis * 1  3/25 (12.00%)  3
Dry skin * 1  2/25 (8.00%)  2
Ecchymosis * 1  2/25 (8.00%)  2
Erythema * 1  2/25 (8.00%)  2
Palmar-plantar erythrodysaesthesia syndrome * 1  2/25 (8.00%)  2
Petechiae * 1  2/25 (8.00%)  2
Purpura * 1  2/25 (8.00%)  2
Scab * 1  2/25 (8.00%)  2
Skin disorder * 1  2/25 (8.00%)  2
Skin ulcer * 1  2/25 (8.00%)  2
Vascular disorders   
Hypotension * 1  9/25 (36.00%)  9
Hypertension * 1  4/25 (16.00%)  4
Flushing * 1  2/25 (8.00%)  2
1
Term from vocabulary, MedDRA version 20
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01352286     History of Changes
Other Study ID Numbers: 209393
ADP 01411 ( Other Identifier: Adaptimmune Therapeutics )
First Submitted: May 4, 2011
First Posted: May 11, 2011
Results First Submitted: July 10, 2018
Results First Posted: January 3, 2019
Last Update Posted: January 3, 2019