NCT02822495

Brief 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 registration of tabelecleucel.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2016

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

First QC Date

June 30, 2016

Last Update Submit

June 13, 2023

Conditions

Epstein-Barr Virus (EBV) InfectionsLymphoproliferative DisordersEBV+ Associated LymphomaEBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)Epstein-Barr ViremiaLymphoma, AIDS-relatedEpstein-Barr Virus-associated Lymphoproliferative Disease (EBV+ LPD) With Primary Immunodeficiency (PID)Leiomyosarcoma (LMS)Nasopharyngeal Carcinoma (NPC)Epstein-Barr Virus-associated Lymphoproliferative Disease (EBV+ LPD) With Acquired Immunodeficiency (AID)Solid Organ Transplant ComplicationsStem Cell Transplant Complications

Keywords

Epstein-Barr Virus (EBV)Solid Organ Transplant (HCT)Hematopoietic Cell Transplant (SOT)Primary Immunodeficiency (PID)Acquired Immunodeficiency (AID)Epstein-Barr Virus-associated LymphomaHIV/AIDS LymphomaRheumatoid Arthritis and LymphomaAllogeneic, Off-The-Shelf T-cell ImmunotherapyTumor Necrosis Factor (TNF)-alpha Inhibitors and LymphomaInflammatory Bowel Disease and LymphomaEpstein-Barr Virus-specific Cytotoxic T lymphocyte (EBV-CTL)Epstein-Barr Virus+ associated Nasopharyngeal Carcinoma (EBV+ NPC)Epstein-Barr Virus+ associated Leiomyosarcoma (EBV+ LMS)

Interventions

tabelecleucelBIOLOGICAL

Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.

Also known as: tab-cel®, ATA129, EBV-CTL

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 38625984DERIVED

MeSH Terms

Conditions

Epstein-Barr Virus InfectionsInfectionsLymphoproliferative DisordersLymphoma, AIDS-RelatedLeiomyosarcomaNasopharyngeal CarcinomaPrimary Immunodeficiency DiseasesArthritis, RheumatoidLymphomaInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueSarcomaCarcinomaNeoplasms, Glandular and EpithelialNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesImmunologic Deficiency SyndromesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Aditi Mehta, DO

    Atara Biotherapeutics

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2016

First Posted

July 4, 2016

Last Updated

June 15, 2023

Record last verified: 2023-06