Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas (CIVIC)
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|ClinicalTrials.gov Identifier: NCT02763254|
Recruitment Status : Terminated (Insufficient recruitment rate)
First Posted : May 5, 2016
Results First Posted : March 12, 2019
Last Update Posted : March 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin Lymphoma Lymphoma, Large B-Cell, Diffuse Post-transplant Lymphoproliferative Disorder||Biological: baltaleucel-T||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Open Label Study to Investigate the Safety and Clinical Activity of Autologous EBV-specific T Cells (CMD-003) for the Treatment of Patients With EBV Positive Lymphomas|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||February 17, 2018|
|Actual Study Completion Date :||February 17, 2018|
Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks.
Autologous EBV-specific T cells
- Best Overall Response [ Time Frame: 1 year ]Best single observed response, complete response (CR) or partial response (PR) per Lugano 2014 Disease Response Criteria, during 12 month follow-up.
- Adverse Events [ Time Frame: 1 year ]Adverse events will be recorded from the time of the first investigational cell product dose is administered until 30 days after the last administration. Serious events recorded for up to 1 year after administration.
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): NCT02763254
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Director:||Kurt Gunter, MD||Cell Medica, Inc|