T Cell Therapy of Opportunistic Cytomegalovirus Infection
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02982902|
Recruitment Status : Recruiting
First Posted : December 6, 2016
Last Update Posted : February 5, 2018
The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV.
Adoptive T-cell therapy is an investigational (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity. These selected T-cells are then infused to the patient, to try to give the immune system the ability to fight the infection. Adoptive T-cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).
|Condition or disease||Intervention/treatment||Phase|
|Cytomegalovirus Infections Hematopoietic Stem Cell Transplant Opportunistic Infections||Biological: CMV specific adoptive t-cells||Early Phase 1|
The primary objective of this study is to determine the feasibility of the treatment of opportunistic cytomegalovirus (CMV) infections after hematopoietic stem cell transplant (HSCT) with virus-specific, antigen-selected T-cells, selected using the CliniMACS prodigy system.
- To describe the safety profile of the infusion of CMV- specific, antigen selected T-cells.
- To describe the toxicities related to infusion of CMV- specific, antigen selected T-cells.
- To describe the rate of eradication of opportunistic CMV infections after HSCT and and treatment with CMV-specific, antigen-selected T-cells using the CliniMACS Prodigy System.
This feasibility study will include a single treatment cohort.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Antigen Specific Adoptive T Cell Therapy for Opportunistic Cytomegalovirus Infection Occurring After Stem Cell Transplant|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2020|
Experimental: CMV specific adoptive t-cells
This study involves a one-time infusion of the experimental CMV specific adoptive t-cells. After this infusion, patients will be followed for 4 weeks.
Biological: CMV specific adoptive t-cells
It is expected that the cell dose will be in the range of 10^3 - 10^5 virus - specific, antigen selected T cells per kg of recipient weight.
Other Name: immunotherapy
- Incidence of adverse events [ Time Frame: Up to 100 days after transplant ]To determine the feasibility of the intervention, the study will record the incidence of adverse events, including graft versus host disease and other complications will be evaluated using binomial distribution theory and their 95% confidence intervals (CIs) will be also estimated using Wilson's method
- Eradication rate of opportunistic CMV infections [ Time Frame: Up to 100 days after transplant ]The eradication rate will be the disappearance of opportunistic CMV infections with the use of CMV-specific, antigen-selected T cells using the CliniMACS Prodigy System over the total number CMV infections.
- response rate [ Time Frame: Up to 100 days after transplant ]A response rate of 25% is considered unacceptable; and the anticipated response rate is approximately 55% for the study population using the cell therapy.
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): NCT02982902
|Contact: Paolo F Caimi, MDemail@example.com|
|United States, Ohio|
|University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44106-5065|
|Contact: Paolo F. Caimi 216-844-0139 firstname.lastname@example.org|
|Principal Investigator: Paolo F. Caimi|
|Principal Investigator:||Paolo F Caimi, MD||University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center|