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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
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.
1 July 2019
Quick facts
| Lead sponsor | Atara Biotherapeutics |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 58 |
| Start date | 1 March 1995 |
| Primary completion | 1 July 2019 |
| Estimated completion | 1 July 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Epstein-Barr virus-specific cytotoxic T lymphocytes (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 of Developing a Recurrent EBV Lymphoma — all drugs for Transplant Patients With EBV Viremia at High Risk of 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. 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.
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Objective Response Rate (ORR)
Time frame: From Day 1 through 251.1 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
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):
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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 -
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 -
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 -
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 -
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 -
Developing T-cell therapies for lymphoma without receptor engineering.
Grant M, Bollard CM. · · 2017 · cited 6× · PMID 29296911 · DOI 10.1182/bloodadvances.2017009886 -
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
Verify or expand the search:
- PubMed search for NCT00002663
- 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.
- NCT06429800 — A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Systemic Lupus Erythematosus · Phase 1 · withdrawn
- 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 NCT00002663 (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: 18 January 2023
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing