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Therapeutic Effects of Epstein-Barr Virus Immune T-Lymphocytes Derived From a Normal HLA-Compatible Or Partially-Matched Third-Party Donor in the Treatment of EBV Lymphoproliferative Disorders and EBV-Associated Malignancies

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ClinicalTrials.gov Identifier: NCT01498484
Recruitment Status : Completed
First Posted : December 23, 2011
Results First Posted : October 21, 2022
Last Update Posted : October 21, 2022
Sponsor:
Collaborator:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Atara Biotherapeutics

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions EBV-induced Lymphomas
EBV-associated Malignancies
Transplant Patients With EBV Viremia at High Risk for Developing a Recurrent EBV Lymphoma
Intervention Biological: EBV-specific T cells (EBV-CTLs)
Enrollment 87
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HCT EBV+ PTLD R/R Rituximab SOT EBV+ PTLD R/R Rituximab EBV+ AID-LPD EBV+ PID-LPD EBV+ Viremia EBV+ Leiomyosarcoma EBV+ Lymphoma EBV+ NPC EBV+ Other Solid Tumor
Hide Arm/Group Description Participants with Epstein-Barr virus positive (EBV+) posttransplant lymphoproliferative disorders (PTLD) hematopoietic cell transplant (HCT) who were relapse/refractory (R/R) to rituximab received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Participants with EBV+PTLD solid organ transplant (SOT) who were R/R to rituximab or R/R to rituximab and chemotherapy received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After 3 week observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Participants with EBV+ acquired immunodeficiency (AID) lymphoproliferative disorder (LPD) received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Results from participants in this arm are being excluded due to the low single digit numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications in this single center study. Participants with EBV+ primary immunodeficiency (PID) LPD received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Results from participants in this arm are being excluded due to the low single digit numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications in this single center study. Participants with EBV+ viremia received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Results from participants in this arm are being excluded due to the low single digit numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications in this single center study. Participants with EBV+ leiomyosarcoma (LMS) received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Results from participants in this arm are being excluded due to the low single digit numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications in this single center study. Participants with EBV+ lymphoma received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Participants with EBV+ nasopharyngeal carcinoma (NPC) received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Participants with EBV+ other solid tumors received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Results from participants in this arm are being excluded due to the low single digit numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications in this single center study.
Period Title: Overall Study
Started 25 10 3 3 2 3 25 14 2
Completed 11 3 1 0 1 2 3 0 0
Not Completed 14 7 2 3 1 1 22 14 2
Reason Not Completed
Death             6             3             1             1             0             0             10             1             0
Physician Decision             3             2             1             1             0             0             8             13             1
Adverse Event             0             0             0             0             0             1             0             0             0
Withdrawal by Subject             0             0             0             1             0             0             1             0             0
Other             5             2             0             0             1             0             3             0             1
Arm/Group Title HCT EBV+ PTLD R/R Rituximab SOT EBV+ PTLD R/R Rituximab EBV+ Lymphoma EBV+ NPC Total
Hide Arm/Group Description Participants with EBV+ PTLD HCT who were R/R to rituximab received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Participants with EBV+PTLD SOT who were R/R to rituximab or R/R to rituximab and chemotherapy received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After 3 week observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Participants with EBV+ lymphoma received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Participants with EBV+ NPC received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 25 10 25 14 74
Hide Baseline Analysis Population Description
Full analysis set included all participants who received at least one dose of tabelecleucel. Results from arms with <= 3participants (EBV+ AID-LPD, EBV+ PID-LPD, EBV+ Viremia, EBV+ Leiomyosarcoma, and EBV+ Other Solid Tumor) are being excluded due to the low single digit numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications in this single center study.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 10 participants 25 participants 14 participants 74 participants
<18 years
5
  20.0%
4
  40.0%
2
   8.0%
2
  14.3%
13
  17.6%
>=18 years
20
  80.0%
6
  60.0%
23
  92.0%
12
  85.7%
61
  82.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 10 participants 25 participants 14 participants 74 participants
Female
11
  44.0%
7
  70.0%
15
  60.0%
4
  28.6%
37
  50.0%
Male
14
  56.0%
3
  30.0%
10
  40.0%
10
  71.4%
37
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 10 participants 25 participants 14 participants 74 participants
Hispanic or Latino
2
   8.0%
0
   0.0%
1
   4.0%
0
   0.0%
3
   4.1%
Not Hispanic or Latino
4
  16.0%
0
   0.0%
3
  12.0%
3
  21.4%
10
  13.5%
Unknown or Not Reported
19
  76.0%
10
 100.0%
21
  84.0%
11
  78.6%
61
  82.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 10 participants 25 participants 14 participants 74 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   4.0%
0
   0.0%
5
  20.0%
11
  78.6%
17
  23.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  12.0%
1
  10.0%
1
   4.0%
2
  14.3%
7
   9.5%
White
17
  68.0%
9
  90.0%
15
  60.0%
1
   7.1%
42
  56.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
  16.0%
0
   0.0%
4
  16.0%
0
   0.0%
8
  10.8%
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description The ORR is defined as percentage of participants with best overall response of complete remission/response (CR) or partial remission/response (PR) based on investigator's assessment. For participants with clinically and/or radiologically evident EBV LPD or malignancies, CR is complete resolution of all clinical and radiologic evidence of lymphoma, confirmed by biopsy of the affected tissues when indicated, lasting for at least 3 weeks following completion of a cycle of tabelecleucel; and PR is a 50 % or greater reduction in the size of all lymphomatous lesions as determined by computed tomography (CT) or magnetic resonance imaging (MRI) measurements of tumor volume, which was maintained for at least 3 weeks following completion of a cycle of tabelecleucel. For participants without clinically and/or radiologically evident tumors with increasing levels of EBV DNA, CR is clearance of EBV without subsequent development of EBV+ LPD; and PR is at least a 10-fold decrease in EBV DNA levels.
Time Frame From Day 1 through 65.3 months after Day 1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least one dose of tabelecleucel.
Arm/Group Title HCT EBV+ PTLD R/R Rituximab SOT EBV+ PTLD R/R Rituximab EBV+ Lymphoma EBV+ NPC
Hide Arm/Group Description:
Participants with EBV+ PTLD HCT who were R/R to rituximab received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+PTLD SOT who were R/R to rituximab or R/R to rituximab and chemotherapy received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After 3 week observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+ lymphoma received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+ NPC received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 25 10 25 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
68.0
(46.5 to 85.1)
50.0
(18.7 to 81.3)
16.0
(4.5 to 36.1)
14.3
(1.8 to 42.8)
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description The OS is defined as the time from the first dose of tabelecleucel to the date of death due to any cause. The OS was estimated using Kaplan-Meier method. Participants who were lost to follow-up or still alive were censored on the last known-to-be-alive date.
Time Frame From Day 1 through 65.3 months after Day 1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least one dose of tabelecleucel. Participants who were lost to follow-up or still alive were censored on the last known-to-be-alive date.
Arm/Group Title HCT EBV+ PTLD R/R Rituximab SOT EBV+ PTLD R/R Rituximab EBV+ Lymphoma EBV+ NPC
Hide Arm/Group Description:
Participants with EBV+ PTLD HCT who were R/R to rituximab received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+PTLD SOT who were R/R to rituximab or R/R to rituximab and chemotherapy received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After 3 week observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+ lymphoma received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+ NPC received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 25 10 25 14
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(7.1 to NA)
14.9 [2] 
(0.4 to NA)
12.3
(1.5 to 21.6)
NA [1] 
(4.9 to NA)
[1]
Median and upper limit of confidence interval are not estimable due to insufficient events being observed at the time of the analysis.
[2]
Upper limit of confidence interval is not estimable due to insufficient events being observed at the time of the analysis.
3.Secondary Outcome
Title OS Rate at 12 Months
Hide Description Percentage of participants with OS at 12 months are reported. The OS is defined as the time from the first dose of tabelecleucel to the date of death due to any cause. The OS was estimated using Kaplan-Meier method. Participants who were lost to follow-up or still alive were censored on the last known-to-be-alive date.
Time Frame From Day 1 through 12 months after Day 1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least one dose of tabelecleucel. Participants who were lost to follow-up or still alive were censored on the last known-to-be-alive date.
Arm/Group Title HCT EBV+ PTLD R/R Rituximab SOT EBV+ PTLD R/R Rituximab EBV+ Lymphoma EBV+ NPC
Hide Arm/Group Description:
Participants with EBV+ PTLD HCT who were R/R to rituximab received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+PTLD SOT who were R/R to rituximab or R/R to rituximab and chemotherapy received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After 3 week observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+ lymphoma received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+ NPC received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 25 10 25 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
68.0
(46.1 to 82.5)
60.0
(25.3 to 82.7)
50.3
(29.1 to 68.2)
77.9
(45.9 to 92.3)
4.Secondary Outcome
Title OS Follow-up Time
Hide Description The OS follow-up time are reported. The OS is defined as the time from the first dose of tabelecleucel to the date of death due to any cause. The OS was estimated using Kaplan-Meier method. Participants who were lost to follow-up or still alive were censored on the last known-to-be-alive date.
Time Frame From Day 1 through 65.3 months after Day 1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least one dose of tabelecleucel.
Arm/Group Title HCT EBV+ PTLD R/R Rituximab SOT EBV+ PTLD R/R Rituximab EBV+ Lymphoma EBV+ NPC
Hide Arm/Group Description:
Participants with EBV+ PTLD HCT who were R/R to rituximab received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+PTLD SOT who were R/R to rituximab or R/R to rituximab and chemotherapy received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After 3 week observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+ lymphoma received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+ NPC received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 25 10 25 14
Median (Full Range)
Unit of Measure: Months
23.33
(0.6 to 60.6)
14.88
(0.4 to 55.4)
7.20
(0.3 to 65.3)
16.0
(3.2 to 46.5)
5.Secondary Outcome
Title Time to Response (TTR)
Hide Description The TTR is defined as the time from the date of the first dose of tabelecleucel to the date of a PR or CR, whichever occurred first. For participants with clinically and/or radiologically evident EBV LPD or malignancies, CR is defined as complete resolution of all clinical and radiologic evidence of lymphoma, confirmed by biopsy of the affected tissues when indicated, lasting for at least 3 weeks following completion of a cycle of tabelecleucel; and a PR is defined as a 50 % or greater reduction in the size of all lymphomatous lesions as determined by CT or MRI scan measurements of tumor volume, which was maintained for at least 3 weeks following completion of a cycle of tabelecleucel. For participants without clinically and/or radiologically evident tumors with increasing levels of EBV DNA, CR is defined as clearance of EBV without subsequent development of EBV+ LPD; and PR is defined as at least a 10-fold decrease in EBV DNA levels.
Time Frame From Day 1 through 65.3 months after Day 1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set included all participants who received at least one dose of tabelecleucel. Participants who achieved CR or PR were analyzed for this outcome measure.
Arm/Group Title HCT EBV+ PTLD R/R Rituximab SOT EBV+ PTLD R/R Rituximab EBV+ Lymphoma EBV+ NPC
Hide Arm/Group Description:
Participants with EBV+ PTLD HCT who were R/R to rituximab received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+PTLD SOT who were R/R to rituximab or R/R to rituximab and chemotherapy received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After 3 week observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+ lymphoma received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Participants with EBV+ NPC received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 17 5 4 2
Median (Full Range)
Unit of Measure: Months
1.77
(0.7 to 6.4)
3.32
(1.6 to 5.4)
2.28
(1.2 to 8.4)
1.76
(1.2 to 2.3)
Time Frame From Day 1 through 65.3 months after Day 1 dose
Adverse Event Reporting Description Combined AE data for all enrolled participants are reported because few arms had <=3 participants which poses a risk of participant identification with rare indications in this study. Treatment-emergent SAEs includes events collected retrospectively and prospectively per protocol. Non-serious AEs were not collected, hence reported as '0'. In participant flow, 'Deaths' are reported as a reason for study discontinuation, whereas in 'All-Cause Mortality' deaths due to any cause are reported.
 
Arm/Group Title Overall Total
Hide Arm/Group Description All eligible participants with EBV+ received IV infusion of tabelecleucel 2 × 10^6 T-cells/kg on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Overall Total
Affected / at Risk (%)
Total   46/87 (52.87%)    
Hide Serious Adverse Events
Overall Total
Affected / at Risk (%) # Events
Total   46/87 (52.87%)    
Blood and lymphatic system disorders   
Febrile neutropenia  1  5/87 (5.75%)  6
Cardiac disorders   
Atrial fibrillation  1  1/87 (1.15%)  1
Pericardial effusion  1  1/87 (1.15%)  1
Pericarditis constrictive  1  1/87 (1.15%)  1
Endocrine disorders   
Adrenal insufficiency  1  1/87 (1.15%)  1
Diabetes insipidus  1  1/87 (1.15%)  1
Eye disorders   
Periorbital oedema  1  1/87 (1.15%)  2
Gastrointestinal disorders   
Abdominal distension  1  1/87 (1.15%)  1
Ascites  1  1/87 (1.15%)  2
Colitis  1  1/87 (1.15%)  1
Diarrhoea  1  1/87 (1.15%)  1
Dysphagia  1  1/87 (1.15%)  1
Enterocolitis  1  2/87 (2.30%)  2
Nausea  1  1/87 (1.15%)  1
Small intestinal haemorrhage  1  1/87 (1.15%)  1
Vomiting  1  1/87 (1.15%)  1
General disorders   
Death  1  13/87 (14.94%)  13
Non-cardiac chest pain  1  2/87 (2.30%)  2
Pyrexia  1  8/87 (9.20%)  8
Hepatobiliary disorders   
Cholecystitis  1  1/87 (1.15%)  1
Hepatic failure  1  1/87 (1.15%)  1
Hepatobiliary disease  1  1/87 (1.15%)  1
Infections and infestations   
Clostridium difficile infection  1  1/87 (1.15%)  1
Device related infection  1  3/87 (3.45%)  3
Gastroenteritis  1  1/87 (1.15%)  1
Influenza  1  1/87 (1.15%)  1
Lower respiratory tract infection  1  1/87 (1.15%)  1
Lung infection  1  10/87 (11.49%)  13
Otitis media  1  1/87 (1.15%)  1
Periorbital infection  1  1/87 (1.15%)  1
Pharyngitis  1  1/87 (1.15%)  1
Pneumonia  1  1/87 (1.15%)  1
Sepsis  1  3/87 (3.45%)  3
Sinusitis  1  3/87 (3.45%)  3
Skin infection  1  2/87 (2.30%)  3
Upper respiratory tract infection  1  1/87 (1.15%)  1
Urinary tract infection  1  1/87 (1.15%)  1
Injury, poisoning and procedural complications   
Vascular access complication  1  1/87 (1.15%)  1
Investigations   
Lymphocyte count decreased  1  2/87 (2.30%)  2
Neutrophil count decreased  1  2/87 (2.30%)  2
Metabolism and nutrition disorders   
Acidosis  1  1/87 (1.15%)  1
Dehydration  1  3/87 (3.45%)  3
Hyperglycaemia  1  1/87 (1.15%)  1
Hypoglycaemia  1  1/87 (1.15%)  1
Hypokalaemia  1  1/87 (1.15%)  1
Hyponatraemia  1  1/87 (1.15%)  1
Tumour lysis syndrome  1  1/87 (1.15%)  1
Musculoskeletal and connective tissue disorders   
Joint effusion  1  1/87 (1.15%)  1
Muscular weakness  1  1/87 (1.15%)  1
Osteonecrosis  1  1/87 (1.15%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Second primary malignancy  1  1/87 (1.15%)  2
Nervous system disorders   
Cerebrovascular accident  1  2/87 (2.30%)  2
Depressed level of consciousness  1  2/87 (2.30%)  3
Encephalopathy  1  1/87 (1.15%)  1
Seizure  1  1/87 (1.15%)  1
Psychiatric disorders   
Confusional state  1  3/87 (3.45%)  4
Mental status changes  1  1/87 (1.15%)  1
Suicide attempt  1  1/87 (1.15%)  1
Renal and urinary disorders   
Acute kidney injury  1  4/87 (4.60%)  4
Chronic kidney disease  1  1/87 (1.15%)  1
Renal disorder  1  1/87 (1.15%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  2/87 (2.30%)  2
Epistaxis  1  1/87 (1.15%)  1
Hypoxia  1  2/87 (2.30%)  2
Oropharyngeal pain  1  1/87 (1.15%)  1
Pleural effusion  1  1/87 (1.15%)  1
Pneumonitis  1  1/87 (1.15%)  2
Pulmonary oedema  1  2/87 (2.30%)  2
Respiratory failure  1  2/87 (2.30%)  2
Stridor  1  1/87 (1.15%)  1
Vascular disorders   
Embolism  1  2/87 (2.30%)  2
Hypotension  1  2/87 (2.30%)  3
1
Term from vocabulary, MedDRA (22.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Overall Total
Affected / at Risk (%) # Events
Total   0/0    
In this investigator-led study, scans were only collected as clinically indicated in lieu of a defined schedule; therefore, disease assessment endpoints (duration of response, durable response rate, progression-free survival, time to progression) may not be reliable, hence not reported. Study 11-130 was designed for patient treatment and conducted mostly as investigator-sponsored, single-center until Atara assumed responsibility, then relevant data was transferred from the investigator to Atara.
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
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Name/Title: Study Director
Organization: Atara Biotherapeutics
Phone: 650-278-8930 ext 1
EMail: clinicalstudies@atarabio.com
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Responsible Party: Atara Biotherapeutics
ClinicalTrials.gov Identifier: NCT01498484    
Other Study ID Numbers: 11-130
First Submitted: December 21, 2011
First Posted: December 23, 2011
Results First Submitted: June 30, 2022
Results First Posted: October 21, 2022
Last Update Posted: October 21, 2022