Partially HLA-matched Third Party Antigen Specific T-cells for Infection Post-stem Cell or Solid Organ Transplantation (R3ACT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02779439|
Recruitment Status : Unknown
Verified July 2016 by David Gottlieb, University of Sydney.
Recruitment status was: Recruiting
First Posted : May 20, 2016
Last Update Posted : July 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|CMV Infection EBV Adenovirus||Biological: Virus specific CTLs||Phase 1|
The study will analyse the safety and biological efficacy of administering the investigational products (most closely HLA-matched third party donor-derived T cells stimulated with viral or fungal antigen expressing DC), for the treatment of viral reactivation and/or infection or fungal infection following allogeneic blood or marrow or solid organ transplantation. The cells will be given therapeutically after transplantation in patients with active viral reactivation or proven/probably fungal infection despite standard therapy.
Our AIMS are to study the safety of third party donor-derived CTL infusions, their effect on treatment of viral reactivation as well as their effect on reconstitution of virus- and fungus-specific immunity, viral and fungal infection and reactivation rates after transplantation, viral load, and use of antiviral and antifungal pharmacotherapy.
We will evaluate the safety of infusions with respect to the development of adverse events within the first 12 months post-CTL infusion and the dynamics of cell persistence by T-cell chimerism analysis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Therapeutic Infusion of Partially HLA-matched Third Party Donor-derived Virus- and Fungus Specific T-lymphocytes in Patients With Active Viral or Fungal Infection Post-allogeneic Stem Cell or Solid Organ Transplantation|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||March 2018|
Experimental: 3rd party CTL infusion
Virus specific CTLs
Biological: Virus specific CTLs
Virus specific CTLs will be given to patients with persistent or recurrent viral reactivation after 2 weeks of standard anti-viral therapy
Other Name: T cells
- Infusion related safety [ Time Frame: 1 week ]infusion related adverse events
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): NCT02779439
|Contact: David Gottlieb, MD FRACPemail@example.com|
|Australia, New South Wales|
|Sydney, New South Wales, Australia, 2145|
|Contact: David Gottlieb, MD FRACP firstname.lastname@example.org|