A Phase 2 interventional study of EBV-specific T cells (EBV-CTLs) in EBV-induced Lymphomas, EBV-associated Malignancies and Transplant Patients With EBV Viremia at High Risk for Developing a Recurrent EBV Lymphoma, sponsored by Atara Biotherapeutics. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-10-21.
Sponsored by Atara Biotherapeutics · Phase 2, Interventional, and Treatment
This is a Phase II trial to evaluate the efficacy and safety of human leukocyte antigen (HLA) partially-matched third-party allogeneic Epstein-Barr virus cytotoxic T lymphocytes (EBV-CTLs) for the treatment of EBV-induced lymphomas and EBV-associated malignancies.
57 studies on the registry are indexed under Viremia; 12 are open to participants now.
This study's enrollment of 87 is close to the median of 87 across 45 interventional studies indexed under Viremia.
Browse Viremia studies →Atara Biotherapeutics is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
OR
OR
Adequate bone marrow, heart, lung, liver and kidney function at the time of treatment with EBV-specificT cells is initiated, including:
It is expected that five types of patients afflicted with EBV-associated lymphomas, lymphoproliferative diseases or malignancies will be referred and will consent to participate in this trial. These are:
Exclusion Criteria:
The following patients will be excluded from this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with Epstein-Barr virus positive (EBV+) posttransplant lymphoproliferative disorders (PTLD) hematopoietic cell transplant (HCT) who were relapse/refractory (R/R) to rituximab will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be 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.
Biological: EBV-specific T cells (EBV-CTLs)
Patients with EBV+PTLD solid organ transplant (SOT) who were R/R to rituximab or R/R to rituximab and chemotherapy will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be 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.
Biological: EBV-specific T cells (EBV-CTLs)
Patients with EBV+ acquired immunodeficiency (AID) lymphoproliferative disorder (LPD) will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be 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
Biological: EBV-specific T cells (EBV-CTLs)
Patients with EBV+ primary immunodeficiency (PID) LPD will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be 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.
Biological: EBV-specific T cells (EBV-CTLs)
Patients with EBV+ viremia will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be 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.
Biological: EBV-specific T cells (EBV-CTLs)
Patients with EBV+ leiomyosarcoma (LMS) will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be 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.
Biological: EBV-specific T cells (EBV-CTLs)
Patients with EBV+ lymphoma will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be 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.
Biological: EBV-specific T cells (EBV-CTLs)
Patients with EBV+ nasopharyngeal carcinoma (NPC) will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be 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.
Biological: EBV-specific T cells (EBV-CTLs)
Patients with EBV+ other solid tumors will receive IV infusion of tabelecleucel 2 × 10\^6 T-cells/kg on Days 1, 8, and 15 and will be 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.
Biological: EBV-specific T cells (EBV-CTLs)
EBV-CTLs are cytotoxic T lymphocytes that specifically kill cells presenting EBV protein antigens including EBV-transformed B lymphocytes responsible for EBV-associated lymphomas and lymphoproliferative disorders.
Also known as: tabelecleucel, tab-cel®, ATA129
Objective Response Rate (ORR)
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
Overall Survival (OS)
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
OS Rate at 12 Months
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
OS Follow-up Time
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
Time to Response (TTR)
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
| Milestone | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 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 |
| Withdrew: Death | 6 | 3 | 1 | 1 | 0 | 0 | 10 | 1 | 0 |
| Withdrew: Physician decision | 3 | 2 | 1 | 1 | 0 | 0 | 8 | 13 | 1 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Other | 5 | 2 | 0 | 0 | 1 | 0 | 3 | 0 | 1 |
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.
| Percentage of participants | HCT EBV+ PTLD R/R Rituximab | SOT EBV+ PTLD R/R Rituximab | EBV+ Lymphoma | EBV+ NPC |
|---|---|---|---|---|
| Objective Response Rate (ORR) | 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) |
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.
| Months | HCT EBV+ PTLD R/R Rituximab | SOT EBV+ PTLD R/R Rituximab | EBV+ Lymphoma | EBV+ NPC |
|---|---|---|---|---|
| Overall Survival (OS) | NA (7.1 to NA) | 14.9 (0.4 to NA) | 12.3 (1.5 to 21.6) | NA (4.9 to NA) |
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.
| Percentage of participants | HCT EBV+ PTLD R/R Rituximab | SOT EBV+ PTLD R/R Rituximab | EBV+ Lymphoma | EBV+ NPC |
|---|---|---|---|---|
| OS Rate at 12 Months | 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) |
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.
| Months | HCT EBV+ PTLD R/R Rituximab | SOT EBV+ PTLD R/R Rituximab | EBV+ Lymphoma | EBV+ NPC |
|---|---|---|---|---|
| OS Follow-up Time | 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) |
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.
| Months | HCT EBV+ PTLD R/R Rituximab | SOT EBV+ PTLD R/R Rituximab | EBV+ Lymphoma | EBV+ NPC |
|---|---|---|---|---|
| Time to Response (TTR) | 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) |
Collected over From Day 1 through 65.3 months after Day 1 dose. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall Total | 46/87 (52.9%) | 46/87 (52.9%) | — |
| Event | Overall Total |
|---|---|
| DeathGeneral disorders | 13/87 |
| Lung infectionInfections and infestations | 10/87 |
| PyrexiaGeneral disorders | 8/87 |
| Febrile neutropeniaBlood and lymphatic system disorders | 5/87 |
| Acute kidney injuryRenal and urinary disorders | 4/87 |
| Device related infectionInfections and infestations | 3/87 |
| SepsisInfections and infestations | 3/87 |
| SinusitisInfections and infestations | 3/87 |
| DehydrationMetabolism and nutrition disorders | 3/87 |
| Confusional statePsychiatric disorders | 3/87 |
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(Participants) | HCT EBV+ PTLD R/R Rituximab | SOT EBV+ PTLD R/R Rituximab | EBV+ Lymphoma | EBV+ NPC | Total |
|---|---|---|---|---|---|
| <18 years | 5 | 4 | 2 | 2 | 13 |
| >=18 years | 20 | 6 | 23 | 12 | 61 |
| Sex: Female, Male(Participants) | HCT EBV+ PTLD R/R Rituximab | SOT EBV+ PTLD R/R Rituximab | EBV+ Lymphoma | EBV+ NPC | Total |
|---|---|---|---|---|---|
| Female | 11 | 7 | 15 | 4 | 37 |
| Male | 14 | 3 | 10 | 10 | 37 |
| Ethnicity (NIH/OMB)(Participants) | HCT EBV+ PTLD R/R Rituximab | SOT EBV+ PTLD R/R Rituximab | EBV+ Lymphoma | EBV+ NPC | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 1 | 0 | 3 |
| Not Hispanic or Latino | 4 | 0 | 3 | 3 | 10 |
| Unknown or Not Reported | 19 | 10 | 21 | 11 | 61 |
| Race (NIH/OMB)(Participants) | HCT EBV+ PTLD R/R Rituximab | SOT EBV+ PTLD R/R Rituximab | EBV+ Lymphoma | EBV+ NPC | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 5 | 11 | 17 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 1 | 2 | 7 |
| White | 17 | 9 | 15 | 1 | 42 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 0 | 4 | 0 | 8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2011 to primary completion in Jul 2019, 91 months.
Results were first posted in Oct 2022, 3 years 3 months after primary completion. A results delay was requested in Jul 2020.
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Studies of the drug tested here: Tabelecleucel
Atara Biotherapeutics