Epstein-Barr Virus (EBV) InfectionsNCT02822495
Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies
A study testing tabelecleucel in people with Epstein-Barr Virus (EBV) Infections and Lymphoproliferative Disorders, run by Atara Biotherapeutics.
Trial summary
The primary objective of this protocol is to provide expanded access to tabelecleucel to participants with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options, and who are not eligible to enroll in clinical studies designed to support the development and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders, EBV+ Associated Lymphoma
- What is being tested?
- tabelecleucel
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Any of the following diagnoses of EBV+ malignancies or disease:
- EBV+ PTLD following allogeneic hematopoietic cell transplant (HCT)
- EBV+ PTLD following solid organ transplant (SOT)
- Persistent EBV viremia and known or suspected immunodeficiency
- EBV+ LPD that has developed in the setting of an AID
- EBV+ LPD that has developed in the setting of a known or suspected PID
Show all 16Show fewer
- EBV+ LMS
- EBV+ NPC
- The evidence of EBV positivity
- Relapsed or refractory disease, defined as failure to achieve response (ie, complete response or partial response) or recurrent disease following first line therapy, ie, systemic therapy for EBV-related malignancy or viremia for which there are no appropriate therapies.
- Not eligible for any other Atara clinical development study
- For participants developing PTLD following allogeneic HCT for acute leukemia, the underlying acute leukemia must be in morphologic remission
- Adequate organ function per the following:
- Absolute neutrophil count >= 500/μL, with or without cytokine support
- Platelet count >= 20,000/μL, with or without transfusion support
- Participant or participant's representative is willing and able to provide written informed consent
Who cannot join
- Current diagnosis of Burkitt's lymphoma, classical Hodgkin's lymphoma, or any T-cell lymphoma
- Prior treatment with any investigational product within 4 weeks of first treatment with tabelecleucel, or within 5 half-lives from the most recent dose to first treatment with tabelecleucel
- Ongoing need for methotrexate or extracorporeal photopheresis; steroid doses > 1 mg/kg/day of prednisone (or equivalent)
- Need for vasopressor or ventilatory support, unless deemed to be caused by the EBV-driven process that tabelecleucel is intended to treat
- Antithymocyte globulin, alemtuzumab, or similar anti-T-cell antibody therapy, or T-cell immunotherapy (donor lymphocyte infusion, other cytotoxic T lymphocytes [CTLs]) <= 4 weeks prior to first treatment with tabelecleucel
- Pregnancy
- Female of childbearing potential or male with a female partner of childbearing potential, either of whom are unwilling to use a highly effective method of contraception
About this study
Official title: Expanded Access Protocol for Providing Tabelecleucel to Patients With Epstein-Barr Virus-Associated Viremia or Malignancies for Whom There Are No Appropriate Alternative Therapies
The primary objective of this protocol is to provide expanded access to tabelecleucel to participants with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options, and who are not eligible to enroll in clinical studies designed to support the development and registration of tabelecleucel.
Read the detailed description
Participants for whom there are no other appropriate therapeutic options and who are not eligible to enroll in other tabelecleucel clinical studies, may be enrolled in this study. After the screening period, participants will receive intravenous infusions of tabelecleucel (1.6 to 2 × 10^6cells/kg) on Day 1, Day 8, and Day 15 of every 35-day cycle. Clinical assessment of disease response is recommended approximately 15 days after the last dose of tabelecleucel to assess the need for additional treatment. The end of expanded access protocol (EAP) visit should be performed at 30 days after the last dose of tabelecleucel.
- Conditions
- Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders, EBV+ Associated Lymphoma, EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Epstein-Barr Viremia, Lymphoma, AIDS-related
- Being tested
- tabelecleucel
- Keywords
- Epstein-Barr Virus (EBV), Solid Organ Transplant (HCT), Hematopoietic Cell Transplant (SOT), Primary Immunodeficiency (PID), Acquired Immunodeficiency (AID), Epstein-Barr Virus-associated Lymphoma, HIV/AIDS Lymphoma, Rheumatoid Arthritis and Lymphoma, Allogeneic, Off-The-Shelf T-cell Immunotherapy, Tumor Necrosis Factor (TNF)-alpha Inhibitors and Lymphoma, Inflammatory Bowel Disease and Lymphoma, Epstein-Barr Virus-specific Cytotoxic T lymphocyte (EBV-CTL), Epstein-Barr Virus+ associated Nasopharyngeal Carcinoma (EBV+ NPC), Epstein-Barr Virus+ associated Leiomyosarcoma (EBV+ LMS)
- Medical subject headings
- Epstein-Barr Virus Infections, Infections, Lymphoproliferative Disorders, Lymphoma, AIDS-Related, Leiomyosarcoma, Nasopharyngeal Carcinoma, Primary Immunodeficiency Diseases, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tabelecleucelBiological
Also called tab-cel®, ATA129, EBV-CTL
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epstein-Barr Virus (EBV) InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Atara Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aditi Mehta, DO, Study director, Atara Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822495
- Sponsor's protocol ID
- ATA129-EAP-901
- Other IDs
- EBV-CTL-201
- Status last verified
- Jun 2023
- First submitted
- 30 Jun 2016
- Last updated
- 15 Jun 2023
- Results posted
- No
Publications
Nikiforow S, Whangbo JS, Reshef R, Tsai DE, Bunin N, Abu-Arja R, Mahadeo KM, Weng WK, Van Besien K, Loeb D, Nasta SD, Nemecek ER, Zhao W, Sun Y, Galderisi F, Wahlstrom J, Mehta A, Gamelin L, Dinavahi R, Prockop S. Tabelecleucel for EBV+ PTLD after allogeneic HCT or SOT in a multicenter expanded access protocol. Blood Adv. 2024 Jun 25;8(12):3001-3012. doi: 10.1182/bloodadvances.2023011626.
PubMed 38625984
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Protocol for Providing Tabelecleucel to Patients With Epstein-Barr Virus-Associated Viremia or Malignancies for Whom There Are No Appropriate Alternative Therapies
- ClinicalTrials.gov ID
- NCT02822495
- Acronym / sponsor ID
- ATA129-EAP-901
- Conditions
- Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders, EBV+ Associated Lymphoma, EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Epstein-Barr Viremia, Lymphoma, AIDS-related
- Keywords
- Epstein-Barr Virus (EBV), Solid Organ Transplant (HCT), Hematopoietic Cell Transplant (SOT), Primary Immunodeficiency (PID), Acquired Immunodeficiency (AID), Epstein-Barr Virus-associated Lymphoma, HIV/AIDS Lymphoma, Rheumatoid Arthritis and Lymphoma
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Atara BiotherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this protocol is to provide expanded access to tabelecleucel to participants with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options, and who are not eligible to enroll in clinical studies designed to support the development and registration of tabelecleucel.
Detailed description
Participants for whom there are no other appropriate therapeutic options and who are not eligible to enroll in other tabelecleucel clinical studies, may be enrolled in this study. After the screening period, participants will receive intravenous infusions of tabelecleucel (1.6 to 2 × 10^6cells/kg) on Day 1, Day 8, and Day 15 of every 35-day cycle. Clinical assessment of disease response is recommended approximately 15 days after the last dose of tabelecleucel to assess the need for additional treatment. The end of expanded access protocol (EAP) visit should be performed at 30 days after the last dose of tabelecleucel.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Any of the following diagnoses of EBV+ malignancies or disease:
- The evidence of EBV positivity
- Relapsed or refractory disease, defined as failure to achieve response (ie, complete response or partial response) or recurrent disease following first line therapy, ie, systemic therapy for EBV-related malignancy or viremia for which there are no appropriate therapies.
- Not eligible for any other Atara clinical development study
- For participants developing PTLD following allogeneic HCT for acute leukemia, the underlying acute leukemia must be in morphologic remission
Key exclusion criteria (7 listed)
- Current diagnosis of Burkitt's lymphoma, classical Hodgkin's lymphoma, or any T-cell lymphoma
- Prior treatment with any investigational product within 4 weeks of first treatment with tabelecleucel, or within 5 half-lives from the most recent dose to first treatment with tabelecleucel
- Ongoing need for methotrexate or extracorporeal photopheresis; steroid doses > 1 mg/kg/day of prednisone (or equivalent)
- Need for vasopressor or ventilatory support, unless deemed to be caused by the EBV-driven process that tabelecleucel is intended to treat
- Antithymocyte globulin, alemtuzumab, or similar anti-T-cell antibody therapy, or T-cell immunotherapy (donor lymphocyte infusion, other cytotoxic T lymphocytes [CTLs]) <= 4 weeks prior to first treatment with tabelecleucel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tabelecleucelAlso: tab-cel®, ATA129, EBV-CTLTabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Derived from this study: PubMed 38625984Nikiforow S, Whangbo JS, Reshef R, Tsai DE, Bunin N, Abu-Arja R, Mahadeo KM, Weng WK, Van Besien K, Loeb D, Nasta SD, Nemecek ER, Zhao W, Sun Y, Galderisi F, Wahlstrom J, Mehta A, Gamelin L, Dinavahi R, Prockop S. Tabelecleucel for EBV+ PTLD after allogeneic HCT or SOT in a multicenter expanded access protocol. Blood Adv. 2024 Jun 25;8(12):3001-3012. doi: 10.1182/bloodadvances.2023011626.
Related trials for Epstein-Barr Virus (EBV) Infections
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
RecruitingPhase 3
International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020)
B-Cell Acute Lymphoblastic Leukaemia
RecruitingPhase 1
mRNA Vaccine Targeting Epstein-Barr Virus (EBV) in Healthy Young Adults
EBV
RecruitingPhase 1/2
CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies
B-NHL, B-Non Hodgkin Lymphoma
Active, not recruitingPhase 1
Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia
B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma, B-Cell Prolymphocytic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aditi Mehta, DO study director
Atara Biotherapeutics
Questions about this trial
What is this clinical trial studying?
A study testing tabelecleucel in people with Epstein-Barr Virus (EBV) Infections and Lymphoproliferative Disorders, run by Atara Biotherapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02822495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.