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
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|ClinicalTrials.gov Identifier: NCT01498484|
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : July 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|EBV-induced Lymphomas EBV-associated Malignancies Transplant Patients With EBV Viremia at High Risk for Developing a Recurrent EBV Lymphoma||Biological: EBV-specific T cells (EBV-CTLs)||Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||December 2011|
|Actual Primary Completion Date :||July 2019|
|Actual Study Completion Date :||July 2019|
Experimental: EBV-specific T cells
Patients will each receive a course of three weekly infusions of EBV-specific T cells (EBV-CTLs). Each weekly dose will provide 2 x 10^6 T cells/kg recipient weight (+/- 3 days). After the third dose, patients will be observed for approximately 3 weeks.
Biological: EBV-specific T cells (EBV-CTLs)
EBV-CTLs are cytotoxic T lymphocytes that specifically kill cells presenting EBV protein antigens including EBV-transformed B lymphocytes responsible for EBV-associated lymphomas and lymphoproliferative disorders.
- Efficacy as defined by response rate [ Time Frame: 1 year ]
- In vivo expansion and duration of EBV-CTLs measured via CTLp assay over time (cells/mL/time) [ Time Frame: 1 year ]
- Durability of clinical responses (time) [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498484
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Study Director:||Minoti Hiremath, MD||Atara Biotherapeutics|