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NCT01498484
A Phase II Study of the 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
Phase 2 trial testing EBV-specific T cells (EBV-CTLs) in EBV-induced Lymphomas in 87 participants. Completed in 1 July 2019.
1 July 2019
Quick facts
| Lead sponsor | Atara Biotherapeutics |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 87 |
| Start date | 1 December 2011 |
| Primary completion | 1 July 2019 |
| Estimated completion | 1 July 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- EBV-specific T cells (EBV-CTLs) — full drug profile →
Conditions studied
- EBV-induced Lymphomas — all drugs for EBV-induced Lymphomas →
- EBV-associated Malignancies — all drugs for EBV-associated Malignancies →
- Transplant Patients With EBV Viremia at High Risk for Developing a Recurrent EBV Lymphoma — all drugs for Transplant Patients With EBV Viremia at High Risk for Developing a Recurrent EBV Lymphoma →
Sponsor
Atara Biotherapeutics — full company profile →
Who can join
Eligibility, any sex, with EBV-induced Lymphomas or EBV-associated Malignancies. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Objective Response Rate (ORR)
Time frame: From Day 1 through 65.3 months after Day 1 dose
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 i
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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 -
Targeting the signaling in Epstein-Barr virus-associated diseases: mechanism, regulation, and clinical study.
Cao Y, Xie L, Shi F, Tang M, et al · · 2021 · cited 86× · PMID 33436584 · DOI 10.1038/s41392-020-00376-4 -
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 -
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 -
Therapeutic approaches to Epstein-Barr virus cancers.
Soldan SS, Messick TE, Lieberman PM. · · 2022 · cited 14× · PMID 36174496 · DOI 10.1016/j.coviro.2022.101260 -
Molecular mechanisms of viral oncogenesis in haematological malignancies: perspectives from metabolic reprogramming, epigenetic regulation and immune microenvironment remodeling.
Xiao Q, Liu Y, Shu X, Li Y, et al · · 2025 · cited 9× · PMID 40349096 · DOI 10.1186/s40164-025-00655-2 -
HBV-associated DLBCL of poor prognosis: advance in pathogenesis, immunity and therapy.
Wan X, Young KH, Bai O. · · 2023 · cited 8× · PMID 37483605 · DOI 10.3389/fimmu.2023.1216610 -
Adoptive cell therapy in paediatric extracranial solid tumours: current approaches and future challenges.
Zappa E, Vitali A, Anders K, Molenaar JJ, et al · · 2023 · cited 7× · PMID 37832507 · DOI 10.1016/j.ejca.2023.113347
Verify or expand the search:
- PubMed search for NCT01498484
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Atara Biotherapeutics trials
Trials by the same sponsor.
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- NCT06256484 — A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Relapsed/Refractory B-cell Non-H · Phase 1 · terminated
- NCT03769467 — Tabelecleucel in Combination With Pembrolizumab in Subjects With Epstein-Barr Virus-associated Nasopharyngeal Carcinoma · Phase 1, PHASE2 · terminated
- NCT03283826 — Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis · Phase 1, PHASE2 · terminated
- NCT02822495 — Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies · no longer available
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01498484 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Atara Biotherapeutics
- Last refreshed: 26 September 2022
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/NCT01498484.
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