Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis
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|ClinicalTrials.gov Identifier: NCT03594981|
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : October 12, 2018
This Phase I-II dose-finding trial to determine the optimal dose of intravenous (IV) injection dose of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, BKV and Adenovirus. A maximum of 36 patients will be treated in up to 18 cohorts each of size 2, with the first cohort treated at the lowest dose level 1, all successive doses chosen by the EffTox method, and no untried dose level skipped when escalating.
The scientific goal of the trial is to determine an optimal IV-CTL cell dose level among the three doses 1.0x107cells/m2, 2 x107cells/m2 and 5x107cells/m2., hereafter dose levels 1, 2, 3. Dose-finding will be done using the sequentially adaptive EffTox trade-off-based design of Thall et al.
|Condition or disease||Intervention/treatment||Phase|
|Viral Infection||Biological: CMV/AdV /EBV/BKV specific T cells||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adoptive Cord Blood ImmunotHerapy Using Expanded Cord Blood T Cells for EBV, CMV, BKV and Adenovirus Reactivation/Infection or ProphylaxiS|
|Actual Study Start Date :||January 24, 2018|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||November 2022|
Experimental: CMV/AdV /EBV/BKV specific T cells
CMV/AdV /EBV/BKV specific T cells will be thawed or thawed and diluted into a total volume of 10 mL of Plasmalyte A and given by slow intravenous injection over 1-2 minutes. Three dose levels will be explored. The lowest dose level will be 1x107cells/m2 and the highest will be 5x107/m2.
Biological: CMV/AdV /EBV/BKV specific T cells
At each dose level, two to six patients will be treated and observed for 45 days for toxicity, dose escalation and for GvHD. If one of the initial cohort of two patients experience Dose Limiting Toxicity (DLT), then four additional patients will be treated at this dose level. If two or more of the six patients experience DLT, then this dose level will be considered unacceptable toxicity and the number of infused CTL will be de-escalated unless we are at the initial dosing levels. If 1x107CTL/m2 results in unacceptable toxicity, the study will be closed to accrual.
- Number of participants with investigational product-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 45 days for toxicity ]The study will determine the safety, toxicity and maximum tolerated dose (MTD) after administering of intravenous injection of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, Adenovirus and BK virus( BKV) given to patients with or at risk for CMV, EBV, BK virus and adenovirus infection after cord blood transplant. The safety will be assessed by investigational product-related adverse events as per CTCAE v4.03.
- Impact of CMV/AdV /EBV/BKV specific T cells will be measured by existence of cells in the system. [ Time Frame: 12 months ]To evaluate the impact of CTLs on CMV/AdV /EBV/BKV -specific T-lymphocyte immune reconstitution. The impact will be evaluated by the number of months/years of cell survival.
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): NCT03594981
|Contact: Allistair Abraham, MD||202-476-5772||AAbraham@childrensnational.org|
|Contact: Fahmida Hoq, MBBS, MSfirstname.lastname@example.org|
|United States, District of Columbia|
|Children's National Health System||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Fahmida Hoq, MBBS, MS 202-476-3634 email@example.com|
|Study Director:||Fahmida Hoq, MBBS, MS||Children's National Health System|