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NCT00002663

An Evaluation of the Toxicity and Therapeutic Effects of Epstein-Barr Virus-Immune T-Lymphocytes Derived From a Normal HLA-Compatible or Haplotype-Matched Donor in the Treatment of EBV-Associated Lymphoproliferative Diseases or Malignancies and Patients With Detectable Circulating Levels of EBV DNA Who Are at High Risk for EBV-Associated Lymphoproliferative Diseases

Completed Phase 1/Phase 2 Results posted Last updated 18 January 2023
What this trial tests

Phase 1/Phase 2 trial testing Epstein-Barr virus-specific cytotoxic T lymphocytes (EBV-CTLs) in EBV-induced Lymphomas in 58 participants. Completed in 1 July 2019.

Timeline
1 March 1995
Primary endpoint
1 July 2019
1 July 2019

Quick facts

Lead sponsorAtara Biotherapeutics
PhasePhase 1/Phase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment58
Start date1 March 1995
Primary completion1 July 2019
Estimated completion1 July 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Atara Biotherapeutics — full company profile →

Who can join

Eligibility, any sex, with EBV-induced Lymphomas or EBV-associated Malignancies. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The purpose of this phase I/II trial is to study the side effects and best dose of biological therapy to treat patients at high-risk or with Epstein-Barr virus-associated lymphoma or lymphoproliferative disease.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Off-the-shelf EBV-specific T cell immunotherapy for rituximab-refractory EBV-associated lymphoma following transplantation.
    Prockop S, Doubrovina E, Suser S, Heller G, et al · · 2020 · cited 190× · PMID 31689242 · DOI 10.1172/jci121127
  2. Novel Immunotherapies for T Cell Lymphoma and Leukemia.
    Ghione P, Moskowitz AJ, De Paola NEK, Horwitz SM, et al · · 2018 · cited 27× · PMID 30317410 · DOI 10.1007/s11899-018-0480-8
  3. Cell therapies for hematological malignancies: don't forget non-gene-modified t cells!
    Grant ML, Bollard CM. · · 2018 · cited 22× · PMID 29198753 · DOI 10.1016/j.blre.2017.11.004
  4. Recent Advances in Adult Post-Transplant Lymphoproliferative Disorder.
    Markouli M, Ullah F, Omar N, Apostolopoulou A, et al · · 2022 · cited 18× · PMID 36497432 · DOI 10.3390/cancers14235949
  5. Cells to prevent/treat relapse following allogeneic stem cell transplantation.
    Dietz AC, Wayne AS. · · 2017 · cited 10× · PMID 29222325 · DOI 10.1182/asheducation-2017.1.708
  6. Evolving Paradigms in HIV Malignancies: Review of Ongoing Clinical Trials.
    Bender Ignacio RA, Lin LL, Rajdev L, Chiao E. · · 2018 · cited 9× · PMID 30099376 · DOI 10.6004/jnccn.2018.7064
  7. Developing T-cell therapies for lymphoma without receptor engineering.
    Grant M, Bollard CM. · · 2017 · cited 6× · PMID 29296911 · DOI 10.1182/bloodadvances.2017009886
  8. Adoptive Cell Immunotherapy in Relapse/Refractory Epstein-Barr Virus-Driven Post-Transplant Lymphoproliferative Disorders.
    Canichella M, de Fabritiis P. · · 2025 · cited 2× · PMID 40558101 · DOI 10.3390/antib14020047

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00002663.

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